Label: CAFFEINE tablet
- NDC Code(s): 0363-5009-01
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 18, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Use
-
WARNINGS
Do not use
■ as a substitute for sleep. This product is intended for occasional use only.
■ in children under 12 years of age
- Directions
- Other Information
- INACTIVE INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CAFFEINE
caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 200 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND Size 11mm Flavor Imprint Code 212;212 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5009-01 1 in 1 CARTON 09/28/2021 1 100 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 final part340 09/28/2021 Labeler - Walgreen Company (008965063)