HEAD AND COLD- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tablet

Head and Cold by

Drug Labeling and Warnings

Head and Cold by is a Otc medication manufactured, distributed, or labeled by Hi-Tech Nutraceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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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

INGREDIENTS AND APPEARANCE

HEAD AND COLD 
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tablet

Product 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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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)