FDA.reportPublic FDA data

Head and Cold - Hi-Tech Nutraceuticals, LLC

Manufacturer
Hi-Tech Nutraceuticals, LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:22

Label at a glance#

ProductHead and Cold
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure17 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

activesactives

OTC - ASK DOCTOR SECTION

ask a docask a doc

OTC - ASK DOCTOR/PHARMACIST SECTION

ask doc or pharmask doc or pharm

OTC - DO NOT USE SECTION

do not usedo not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reachkeep out of reach

OTC - PREGNANCY OR BREAST FEEDING SECTION

PregnantPregnant

OTC - PURPOSE SECTION

purposepurpose

OTC - QUESTIONS SECTION

questionsquestions

OTC - STOP USE SECTION

atop useatop use

OTC - WHEN USING SECTION

When usingWhen using

OVERDOSAGE SECTION

overdosageoverdosage

WARNINGS SECTION

warningswarnings

INACTIVE INGREDIENT SECTION

InactivesInactives

INDICATIONS & USAGE SECTION

UsesUses

DOSAGE & ADMINISTRATION SECTION

dosage and admindosage and admin

STORAGE AND HANDLING SECTION

storagestorage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69732-003-012024-01-30C16284748780-11030e365-0c5f-111a-e063-dadaa90a10e2Head and Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69732-003-01Head and Cold30 in 1 BOTTLE, PLASTICTABLET304

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69732-00369732-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
ndc (package): 69732-003-01
ndc (product): 69732-003
ndc11 (package): 69732000301
spl id: 4e541679-127c-5194-e063-6294a90a4e42
spl set id: a39c772b-3cce-14cb-e053-2a95a90a733b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.