HEAD AND COLD- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tablet 
Hi-Tech Nutraceuticals, LLC

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.

----------

Head and Cold

actives

ask a doc

ask doc or pharm

do not use

keep out of reach

Pregnant

purpose

questions

atop use

When using

overdosage

warnings

Inactives

Uses

dosage and admin

storage

PDP

HEAD AND COLD 
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69732-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScorescore with uneven pieces
ShapeCAPSULE (20) Size20mm
FlavorImprint Code HTP540
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69732-003-0130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/30/2020
Labeler - Hi-Tech Nutraceuticals, LLC (606221443)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Nutraceuticals, LLC080787135pack(69732-003)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Nutraceuticals, LLC606221443manufacture(69732-003)

Revised: 12/2022
Document Id: f11c9344-b72b-4cb2-e053-2a95a90aa8a0
Set id: a39c772b-3cce-14cb-e053-2a95a90a733b
Version: 3
Effective Time: 20221231
 
Hi-Tech Nutraceuticals, LLC