Novartis Consumer Health

FDA Food Class II Terminated

Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefiber Fiber Supplement, On-The-Go Stick Packs, Sugar Free, Clear & Taste-Free, p

December 18, 2013 Novartis Consumer Health 57,808/68-ct. pkgs., 142,088/3-ct. pkgs., and 11,678/8/3-ct. pkg. clip strips units

FDA Drug Class III Terminated

Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but

September 3, 2013 Novartis Consumer Health 11,846,608 blister packs units

FDA Food Class III Terminated

Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.

August 6, 2013 Novartis Consumer Health 26,604 units units

FDA Food Class III Terminated

Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.

August 6, 2013 Novartis Consumer Health 70,380 units units

FDA Drug Class III Terminated

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-03

August 6, 2013 Novartis Consumer Health 3,451,224 bottles units

FDA Food Class III Terminated

Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.

August 6, 2013 Novartis Consumer Health 165,480 units units

FDA Drug Class III Terminated

Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign

August 6, 2013 Novartis Consumer Health 46,680 bottles units

FDA Drug Class III Terminated

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc.

August 6, 2013 Novartis Consumer Health 11,760 bottles units

FDA Drug Class III Terminated

Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC

August 6, 2013 Novartis Consumer Health 112,728 bottles units

FDA Drug Class III Terminated

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mi

August 6, 2013 Novartis Consumer Health 129,048 bottles units

FDA Drug Class III Terminated

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc

August 6, 2013 Novartis Consumer Health 117,816 bottles units

FDA Food Class III Terminated

Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.

August 6, 2013 Novartis Consumer Health 504,456 units units

FDA Drug Class III Terminated

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc.,

August 6, 2013 Novartis Consumer Health 23,856 bottles units

FDA Food Class III Terminated

Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.

August 6, 2013 Novartis Consumer Health 419,040 units units

FDA Drug Class III Terminated

Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, N

August 6, 2013 Novartis Consumer Health 149,616 bottles units

FDA Drug Class III Terminated

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consume

August 6, 2013 Novartis Consumer Health 410,220 bottles units

FDA Drug Class II Terminated

Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-coun

June 18, 2013 Novartis Consumer Health 1,202,960 cartons and cards units

FDA Drug Class II Terminated

NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lem

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol &

June 18, 2013 Novartis Consumer Health 917,400 cartons units

FDA Drug Class II Terminated

Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per

June 18, 2013 Novartis Consumer Health 292,320 cartons units

FDA Drug Class II Terminated

Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Rus

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-co

June 18, 2013 Novartis Consumer Health 1,871,122 cartons units

FDA Drug Class II Terminated

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health

June 18, 2013 Novartis Consumer Health 1,140,564 cartons units

FDA Drug Class II Terminated

NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton,

June 18, 2013 Novartis Consumer Health 868,104 cartons units

FDA Drug Class II Terminated

NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Nova

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsip

June 18, 2013 Novartis Consumer Health 398,208 cartons units

FDA Drug Class II Terminated

Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea fl

June 18, 2013 Novartis Consumer Health 3,753,348 cartons units

FDA Drug Class II Terminated

Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 50

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed

June 18, 2013 Novartis Consumer Health 1,614,564 cartons units

FDA Drug Class II Terminated

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per c

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis C

June 6, 2013 Novartis Consumer Health 472,000 pouches units

FDA Drug Class II Terminated

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Pars

June 6, 2013 Novartis Consumer Health a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined) units

FDA Drug Class II Terminated

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203

June 6, 2013 Novartis Consumer Health 10,624,000 pouches units

FDA Drug Class II Terminated

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02

June 6, 2013 Novartis Consumer Health 4,422,000 pouches units

FDA Drug Class III Terminated

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime

May 15, 2013 Novartis Consumer Health 167,712/24-caplet packages units

FDA Drug Class III Terminated

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula

May 15, 2013 Novartis Consumer Health 32,256/24-caplet packages units

FDA Drug Class III Terminated

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 98,024/8-caplet packages and 557,548/24-caplet packages units

FDA Drug Class III Terminated

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

May 15, 2013 Novartis Consumer Health 2,978,000/2-caplet packages units

FDA Drug Class III Terminated

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula an

May 15, 2013 Novartis Consumer Health 104,328/32-caplet packages units

FDA Drug Class III Terminated

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 3,768/8-caplet packages and 300,580/24-caplet packages units

FDA Drug Class III Terminated

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula a

May 15, 2013 Novartis Consumer Health 38,856/24-caplet package units

FDA Food Class II Terminated

Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 1

May 7, 2013 Novartis Consumer Health 226,381 consumer units units

FDA Food Class II Terminated

Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ

May 7, 2013 Novartis Consumer Health 152,016/5.0-oz. (24-ct) boxes units

FDA Food Class II Terminated

Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany,

May 7, 2013 Novartis Consumer Health 110,664/10.76-oz (48 Servings) bottles units

FDA Food Class II Terminated

Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany

May 7, 2013 Novartis Consumer Health 162,408/5.0-oz. (24-ct) boxes units

FDA Food Class II Terminated

Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622.

May 7, 2013 Novartis Consumer Health 170,220/6.4-oz. (48 servings) bottles units

FDA Food Class II Terminated

Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations: (1) 2.8-oz. (20 servings) bottles, UPC 300670044206; (2) 4.6-oz. (32 servings) bottles, UPC 300670044329;

May 7, 2013 Novartis Consumer Health 19,900,520 consumer units units

FDA Drug Class III Terminated

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

April 19, 2013 Novartis Consumer Health 3,828 Tubes units