FDA Label for Acetaminophen

Other

Drug Facts

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.

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

Active Ingredient (In Each Caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

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
  
  

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

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.

Otc - Ask Doctor

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

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

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.

Inactive Ingredients

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

call 1-800-406-7984

Principal Display Panel - 650 Mg Caplet Bottle Carton

COMPARE TO the active ingredient of
TYLENOL^® 8HR *See side panel

NDC 30142-968-01

Kroger_®

USE ONLY AS DIRECTED

OUR PHARMACIST RECOMMENDED

8 Hour Pain Relief^†

Acetaminophen
Extended-Release
Tablets USP, 650 mg
Pain Reliever/Fever Reducer

^†For up to 8 Hour Relief of Minor Muscle Aches & Pain

EASY TO
OPEN
BOTTLE

actual
size

100 CAPLETS**
**capsule-shaped tablets

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton - acetaminophen 01