Label: ACETAMINOPHEN- acetaminophen tablet, extended release
- NDC Code(s): 0363-0340-01, 0363-0340-20, 0363-0340-80
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT (IN EACH GELTAB)
Acetaminophen USP, 650 mgClose
Pain reliever/fever reducerClose
temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- the common cold
- temporarily reduces fever
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
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.
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.
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.
- do not take more than directed (see overdose warning)
- 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 dioxideClose
- PRINCIPAL DISPLAY PANEL
Well at Walgreens
Arthritis Pain Reliever
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever / Fever Reducer
- For the temporary relief of minor arthritis pain
(80+20 FREE) (*Gelatin-Coated tablets)
Compare to Tylenol®Arthritis Pain active ingredient‡‡
DISTRIBUTED BY: WALGREEN CO.
- INGREDIENTS AND APPEARANCE
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)