Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet
- NDC Code(s): 37205-659-72, 37205-659-78
- Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Acetaminophen 500 mgClose
Pain reliever/fever reducerClose
temporarily relieves minor aches and pains due to:
the common cold
minor pain of arthritis
premenstrual and menstrual cramps
temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
more than 4,000 mg of acetaminophen in 24 hours
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.
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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 8 tablets in 24 hours
do not take for more than 10 days unless directed by a doctor
children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
- Other information
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
- Inactive ingredients
corn starch, povidone, sodium starch glycolate*, stearic acid
*may contain this ingredientClose
- Questions or comments?
- Principal Display Panel
Compare to Extra Strength Tylenol® active ingredient†
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-659 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID STARCH, CORN Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 44;148 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-659-72 1 in 1 CARTON 1 60 in 1 BOTTLE 2 NDC:37205-659-78 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 01/21/1993 Labeler - CARDINAL HEALTH (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(37205-659) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(37205-659)