Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen aspirin caffeine tablet, coated
- NDC Code(s): 11822-7897-7
- Packager: RITE AID
- 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.
Drug Label Information
Updated January 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
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.Allergy alert: Aspirin may cause a severe allergic reaction which may include:
• hives
• facial swelling
• shock• asthma (wheezing)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 8 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 productStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. - DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms occurThese could be signs of a serious condition
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen aspirin caffeine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7897 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CARNAUBA WAX (UNII: R12CBM0EIZ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape CAPSULE (Capsule shaped tablet) Size 17mm Flavor Imprint Code TCL370 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-7897-7 1 in 1 CARTON 05/31/2021 1 200 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/31/2021 Labeler - RITE AID (014578892) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(11822-7897)