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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Active Ingredient (In Each Geltab)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

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
  
  

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

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.

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
• the tablet got stuck in your throat

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	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 (corn), titanium dioxide

Questions?

call 1-800-406-7984

Principal Display Panel - 650 Mg Tablet Bottle Label

CVS
Health_™

Compare to the active ingredient
in Tylenol^® 8HR Arthritis Pain*

Geltabs^†

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

8HR Arthritis
Pain Relief
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS, USP 650 mg

Pain reliever; Fever reducer

• For the temporary relief
  of minor arthritis pain
• Lasts up to 8 hours

Use only as directed.

80 GELTABS^†
†GELATIN-COATED TABLETS

Actual Size

PRINCIPAL DISPLAY PANEL - 650 mg Tablet Bottle Label - acetaminophen 01