Label: HEAD AND COLD- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69732-003-01 - Packager: Hi-Tech Nutraceuticals, LLC
- 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 December 31, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- STOP USE
- WHEN USING
- OVERDOSAGE
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEAD AND COLD
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69732-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score score with uneven pieces Shape CAPSULE (20) Size 20mm Flavor Imprint Code HTP540 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69732-003-01 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/30/2020 Labeler - Hi-Tech Nutraceuticals, LLC (606221443) Establishment Name Address ID/FEI Business Operations Hi-Tech Nutraceuticals, LLC 080787135 pack(69732-003) Establishment Name Address ID/FEI Business Operations Hi-Tech Nutraceuticals, LLC 606221443 manufacture(69732-003)
