Acetaminophen ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION INC. FDA Approved Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA076200

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen USP 650 mg
Inactive Ingredients
Inactive ingredients croscarmellose sodium hypromellose magnesium stearate microcrystalline cellulose povidone pregelatinized starch propylene glycol sodium lauryl sulfate stearic acid titanium dioxide
Strengths
650 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Muscular Aches Backache Minor Pain Of Arthritis Toothache Premenstrual And Menstrual Cramps Headache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: white Imprint: cor116

Identifiers & Packaging

Container Type BOTTLE
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton NDC 63868-091-50 QUALITY CHOICE † Compare to Active Ingredient in TYLENOL ® 8 Hour Last up to 8 Hours | Use Only as Directed 8 Hour Pain Relief Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever | Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches & Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 50 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton NDC 63868-091-50 QUALITY CHOICE † Compare to Active Ingredient in TYLENOL ® 8 Hour Last up to 8 Hours | Use Only as Directed 8 Hour Pain Relief Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever | Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches & Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 50 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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 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 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 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 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 excessive heat 40° C (104° F). see end panel for batch number and expiration date 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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