Label: EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated
- NDC Code(s): 15338-703-05, 15338-703-11
- Packager: Apace Packaging, LLC
- This is a repackaged label.
- Source NDC Code(s): 49483-370
- 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 November 13, 2018
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- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- DO NOT USE
Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount;
with other drugs containing acetaminophen;
3 or more alcoholic drinks every day while usng this product
STOMACH 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 (anticogulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)
take more or for a longer time than directed
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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.
- KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EXTRA PAIN RELIEF
acetaminophen, aspirin and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15338-703(NDC:49483-370) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE (CAPSULE SHAPED TABLET) Size 18mm Flavor Imprint Code TCL370 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15338-703-05 50 in 1 BOX, UNIT-DOSE 08/23/2016 1 NDC:15338-703-11 1 in 1 BLISTER PACK; 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 08/23/2016 Labeler - Apace Packaging, LLC (361961142) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc. 037052099 manufacture(15338-703) Establishment Name Address ID/FEI Business Operations Apace Packaging, LLC 361961142 repack(15338-703) , label(15338-703)