ACETAMINOPHEN- acetaminophen tablet, extended release 
Walgreen Company

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Drug Facts

ACTIVE INGREDIENT (IN EACH GELTAB)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

more than 6 geltabs in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

skin reddening
blisters
rash

if a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

Liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
the tablet got stuck in your throat

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

do not take more than directed (see overdose warning)

adults

take 2 geltabs every 8 hours. Swallow only one geltab at a time.
take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 geltabs in 24 hours
do not use for more than 10 days unless directed by a doctor

under 18 years of age

ask a doctor

OTHER INFORMATION

store at 20 - 25° C (68 - 77° F). Avoid high humidity.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

Well at Walgreens

NDC 0363-0340-01

Arthritis Pain Reliever

Acetaminophen Extended-release Tablets USP, 650 mg

Pain Reliever / Fever Reducer

For the temporary relief of minor arthritis pain

100 GELTABS*

(80+20 FREE) (*Gelatin-Coated tablets)

Compare to Tylenol®Arthritis Pain active ingredient‡‡

DISTRIBUTED BY: WALGREEN CO.

5117003/ORG0415-F

This is the 100 count blister carton label for Walgreens Acetaminophen extended-release tablets, USP 650 mg (geltabs).
ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0340
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white (White to Yellow) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 350
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0340-20 20 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0363-0340-80 80 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0363-0340-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078569 12/21/2012
Labeler - Walgreen Company (008965063)
Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE(0363-0340)

Revised: 4/2015
Document Id: afe9ac8d-eee4-4073-8daa-4b517c5e90a7
Set id: a1cec332-5802-4684-8b7f-6cb98da40e8b
Version: 2
Effective Time: 20150428
 
Walgreen Company