Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
view more59779-484-72, 59779-484-76, 59779-484-78, 59779-484-83, 59779-484-85, 59779-484-90, 59779-484-93
- Packager: CVS Pharmacy
- 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 August 10, 2016
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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. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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 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.
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.
- do not take more than directed (see overdose 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
- Inactive ingredients
carnauba wax, corn starch*, croscarmellose sodium*, 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
10% MORE FREE 550 FOR THE PRICE OF 500
Compare to the active ingredient in Extra Strength Tylenol® Caplets
ACETAMINOPHEN 500 mg
Pain reliever; Fever reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
SEE NEW WARNINGS
- INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-484 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 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:59779-484-71 1 in 1 CARTON 10/07/1992 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59779-484-78 1 in 1 CARTON 10/07/1992 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59779-484-85 1 in 1 CARTON 10/07/1992 3 250 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:59779-484-62 1 in 1 CARTON 10/12/1992 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:59779-484-76 1 in 1 CARTON 11/30/1992 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:59779-484-72 1 in 1 CARTON 07/19/2007 6 60 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:59779-484-93 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 8 NDC:59779-484-90 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 9 NDC:59779-484-83 1 in 1 CARTON 02/11/2016 9 225 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:59779-484-52 1 in 1 CARTON 08/22/1995 10 10 in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:59779-484-02 550 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/15/1991 Labeler - CVS Pharmacy (062312574)