Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 19, 2013
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- Active ingredient (in each caplet)
Acetaminophen 500 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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.
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.
- do not take more than directed (see Liver warning)
adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- store at 20-25ºC (68-77ºF)
- Inactive ingredients
carnauba wax*, corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredientsClose
- Questions or comments?
- Principal Display Panel
Easy To Swallow Caplets
COMPARE TO active ingredient of EXTRA STRENGTH TYLENOL®
See bottom panel
Pain Reliever/Fever Reducer
Contains No Aspirin
500 mg EACHClose
- INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-484 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape CAPSULE (caplet) Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-484-71 1 in 1 CARTON 1 50 in 1 BOTTLE 2 NDC:30142-484-78 1 in 1 CARTON 2 100 in 1 BOTTLE 3 NDC:30142-484-85 1 in 1 CARTON 3 250 in 1 BOTTLE 4 NDC:30142-484-90 500 in 1 BOTTLE 5 NDC:30142-484-76 1 in 1 CARTON 5 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/15/1987 Labeler - Kroger Company (006999528)