Hyland's Cold Tablets with Zinc

Manufacturer
Hyland's Inc.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:30:08

Label at a glance#

ProductCOLD
Active ingredientACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ONION, ZINC GLUCONATE
Label structure12 sections

Indications and uses

■ Reduces the duration and severity of common cold symptoms ■ Temporarily relieves symptoms of common cold, including: ■ sneezing ■ runny nose ■ congestion ■ cough ■ sore throat ■ headache ■ watery eyes ■ fever ■ chills

Dosage and administration

Adults and children 12 years and over Dissolve 2 tablets under tongue every 4 hours until relieved. Children 6 years to under 12 years Dissolve 1 tablet under tongue every 4 hours until relieved.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves Runny Nose, Congestion, Sore Throat, Cough, Sneezing, Headache and Fever

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Aconitum Napellus 6X HPUSsneezing, watery eyes, sore throat
Allium Cepa 6X HPUSred/watery eyes, runny nose, nasal discharge
Gelsemium Sempervirens 6X HPUSsneezing, headache, sore throat, cough
Zincum Gluconicum 2X HPUSrunny nose, sore throat

"HPUS" indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Reduces the duration and severity of common cold symptoms
■ Temporarily relieves symptoms of common cold, including:
■ sneezing ■ runny nose ■ congestion
■ cough ■ sore throat ■ headache
■ watery eyes ■ fever ■ chills

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - DO NOT USE SECTION

Do not use more than directed.

OTC - ASK DOCTOR SECTION

Consult a physician if:

■ symptoms persist for more than 7 days or worsen.
■ inflammation, fever (over 101°F) or infection is present or develops.
■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

OTC - DO NOT USE SECTION

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious condition.

SPL UNCLASSIFIED SECTION

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by fever (over 101°F), headache, nausea and vomiting may be serious. Consult a doctor promptly.

OVERDOSAGE SECTION

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children
12 years and over
Dissolve 2 tablets under tongue every 4 hours until relieved.
Children 6 years
to under 12 years
Dissolve 1 tablet under tongue every 4 hours until relieved.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Other information

OTHER SAFETY INFORMATION

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Indications and Usage (Uses)

RECENT MAJOR CHANGES SECTION

Updated to

 Reduces the duration and severity of common cold symptoms
 Temporarily relieves symptoms of common cold, including:
 sneezing  runny nose  congestion
 cough  sore throat  headache
 watery eyes  fever  chills

Dosage and Administration

RECENT MAJOR CHANGES SECTION

Directions

Adults and children
12 years and over

Dissolve 2 tablets under tongue every 4 hours until relieved.

Children 6 years
to under 12 years

Dissolve 1 tablet under tongue every 4 hours until relieved.

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC
NDC 54973-3010-1

AGES 6+

SINCE 1903

Hyland's

Cold Tablets

with Zinc*

SHORTENS

COLDS

MULTI - SYMPTOM RELIEF

Relieves Runny Nose, Congestion, Sore Throat,
Cough, Sneezing, Headache and Fever

Free of Dyes and Preservatives
Non-Drowsy

50 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON SIDE PANEL BELOW DRUGS FACTS

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3010-1COLD1 in 1 CARTONTABLET18
54973-3010-1COLD1 g in 1 BOTTLE, PLASTICTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3010COLD (ACONITUM NAPELLUS, ALLIUM CEPA, GELSEMIUM SEMP., ZINCUM GLUCONICUM) TABLET [HYLAND'S INC.]8Current NDC, Legacy NDC, 2 package rows20250110_120c1c96-dd70-4d54-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q2
ONIONACTIVE INGREDIENT492225Q21H2
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z2
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q2
ONIONACTIVE MOIETY492225Q21H2
ZINC CATIONACTIVE MOIETY13S1S8SF372
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-301054973-3010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
COLDACONITUM NAPELLUS, ALLIUM CEPA, GELSEMIUM SEMP., ZINCUM GLUCONICUMHyland's Inc.120c1c96-dd70-4d54-e054-00144ff8d46c2025-01-08WarningsExact identifier
ndc (package): 54973-3010-1
ndc (product): 54973-3010
ndc11 (package): 54973301001
spl id: 2b382a01-d3ae-775d-e063-6394a90a6916
spl set id: 120c1c96-dd70-4d54-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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