Acetaminophen ACETAMINOPHEN WALGREEN COMPANY FDA Approved 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
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA078569
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each geltab) Acetaminophen USP 650 mg
Inactive Ingredients
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 (corn) titanium dioxide
Strengths
650 mg
Treats Conditions
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
Pill Appearance
Shape: round Color: white Imprint: 350

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label Walgreens Compare to Tylenol ® 8 HR Arthritis Pain active ingredient †† EASY-OPEN NDC 0363-0340-08 Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg / PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR For the temporary relief of minor arthritis pain Lasts up to 8 hours ACTUAL SIZE 80 GELTABS* (*GELATIN-COATED TABLETS) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label Walgreens Compare to Tylenol ® 8 HR Arthritis Pain active ingredient †† EASY-OPEN NDC 0363-0340-08 Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg / PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR For the temporary relief of minor arthritis pain Lasts up to 8 hours ACTUAL SIZE 80 GELTABS* (*GELATIN-COATED TABLETS) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe 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 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.
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 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 & 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 the tablet got stuck in your throat These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

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.

Questions

Questions? call 1-800-406-7984


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