Label: CITRAMON- aspirin acetaminophen caffeine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 16638-118-13 - Packager: Borisovskiy Zavod Medicinskikh Preparatov JSC
- 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 August 24, 2016
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INGREDIENTS AND APPEARANCE
CITRAMON
aspirin acetaminophen caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16638-118 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 220 mg in 550 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg in 550 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 27 mg in 550 mg Inactive Ingredients Ingredient Name Strength COCOA (UNII: D9108TZ9KG) 22.5 mg in 550 mg CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 4.6 mg in 550 mg STARCH, POTATO (UNII: 8I089SAH3T) 68 mg in 550 mg TALC (UNII: 7SEV7J4R1U) 2.4 mg in 550 mg STEARIC ACID (UNII: 4ELV7Z65AP) 7.15 mg in 550 mg Product Characteristics Color brown (Light brown with white inclusions) Score 2 pieces Shape ROUND (Tablet) Size 12mm Flavor COFFEE (Coffee flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16638-118-13 3300 mg in 1 PACKAGE; Type 0: Not a Combination Product 09/11/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/26/1996 Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593) Establishment Name Address ID/FEI Business Operations Borisovskiy Zavod Medicinskikh Preparatov JSC 628149593 manufacture(16638-118)