Acetaminophen ACETAMINOPHEN WALMART INC. FDA Approved Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramp toothache the common cold headache toothache temporarily reduces fever
Generic: ACETAMINOPHEN
Mfr: WALMART INC. FDA #34 OTC
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA207229
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hydroxyethyl cellulose hypromellose magnesium stearate microcrystalline cellulose povidone pregelatinized starch (maize) sodium starch glycolate titanium dioxide triacetin Questions or comments? call 1-888-287-1915 DISTRIBUTED BY: Walmart Inc. Bentonville AR 72716 Made in India Code: TS/DRUGS/22/2009
Strengths
650 mg
Quantities
325 tablet
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Backache Premenstrual And Menstrual Cramp Toothache The Common Cold Headache Toothache Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: I;06

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
362O9ITL9D
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle) TO OPEN: 1. PUSH DOWN NDC 79903-132-25 2. TURN CAP equate TM Compare to Tylenol ® 8 HR Arthritis Pain active ingredient** 8 HOUR Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 650 325 mg Extended-Release EACH Tablets Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle) TO OPEN: 1. PUSH DOWN NDC 79903-132-25 2. TURN CAP equate TM Compare to Tylenol ® 8 HR Arthritis Pain active ingredient** 8 HOUR Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 650 325 mg Extended-Release EACH Tablets Actual Size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (325 Tablet Bottle)

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see overdose warning). Adults: take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor. Under 18 years of age: ask a doctor

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 tablets 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 blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

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 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 & Ask a Doctor

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 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

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.

Storage & Handling

Other information store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). USP Dissolution test is pending


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