FDA.reportPublic FDA data

Cold Remedy Gan Mao Ling

Manufacturer
International Nature Nutraceuticals | Guangdong Yihetang Pharmaceutical Co., Ltd
Effective date
2013-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:52

Label at a glance#

ProductCold Remedy Gan Mao Ling
Active ingredientCAFFEINE, CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies fever headache runny nose itching of the nose or throat minor aches and pains sore throat

Dosage and administration

Adults and children 12 years of age and older: take 4 tablets every 4 hours, not more than 12 tablets in 24 hours Children 6 to 12 years old take 2 tablets every 4 hours, not more than 6 tablets in 24 hours Children under 6 years: consult a doctor

Storage and handling

Store at 15°C to 30°C  (59°F to 86°F) keep away from heat keep in dry place

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Caffeine- 1mg

Chlorpheniramine Maleate- 1mg

Acetaminophen- 50mg

When using this product

INDICATIONS & USAGE SECTION

May occur drowsiness

avoid alcoholic drinks

use caution when you driving a motor vehicle or operating machinery

may occur excitability especially in children

 

Uses

OTC - PURPOSE SECTION

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies

  • fever
  • headache
  • runny nose
  • itching of the nose or throat
  • minor aches and pains
  • sore throat

Warnings

WARNINGS SECTION

Do not use if:

  • Condition worsens
  • pain lasts more than 7 days
  • fever lasts more than 3 days
  • if pregnant or breast-feeding, consult a doctor before using

Ask a doctor/pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • taking sedatives or tranquilizers

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

  • take 4 tablets every 4 hours, not more than 12 tablets in 24 hours

Children 6 to 12 years old

  • take 2 tablets every 4 hours, not more than 6 tablets in 24 hours

Children under 6 years:

  • consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

金盏银盘 Bidens Pilosa Whole 野菊花。  Dendranthema indicum flower. 薄荷油.  Mentha arvensis flower oil. 岗梅 ilex Pedunculosa whole

Storage

STORAGE AND HANDLING SECTION

Store at 15°C to 30°C  (59°F to 86°F)

keep away from heat

keep in dry place

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372644acetaminophen 50 MG / caffeine 1 MG / chlorpheniramine maleate 1 MG Oral TabletPSN1
1372644acetaminophen 50 MG / caffeine 1 MG / chlorpheniramine maleate 1 MG Oral TabletSCD1
1372644APAP 50 MG / Caffeine 1 MG / Chlorpheniramine Maleate 1 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51367-005-102019-11-27C16284748780-19855d018-d415-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51367-005-10Cold Remedy Gan Mao Ling100 in 1 BOXTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51367-005COLD REMEDY GAN MAO LING (CAFFEINE, CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [INTERNATIONAL NATURE NUTRACEUTICALS]1Legacy NDC, 1 package rows20130315_732cd28f-36c2-482c-87a9-270f19fc9015.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
CAFFEINEACTIVE INGREDIENT3G6A5W338E1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
CAFFEINEACTIVE MOIETY3G6A5W338E1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
BIDENS PILOSA WHOLEINACTIVE INGREDIENTAYT02NS64S1
DENDRANTHEMA INDICUM FLOWERINACTIVE INGREDIENTI6OER6U04L1
ILEX PEDUNCULOSA WHOLEINACTIVE INGREDIENT46804GL8SN1
MENTHA ARVENSIS FLOWER OILINACTIVE INGREDIENTQ129Z1W6Y21

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51367-00551367-005-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
ACETAMINOPHEN362O9ITL9DACTIB
BIDENS PILOSA WHOLEAYT02NS64SIACT
DENDRANTHEMA INDICUM FLOWERI6OER6U04LIACT
MENTHA ARVENSIS FLOWER OILQ129Z1W6Y2IACT
ILEX PEDUNCULOSA WHOLE46804GL8SNIACT

Source Document#

Source XML

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
d0a8f2c8-a3d5-4cac-b9bf-c4d8df7e2485732cd28f-36c2-482c-87a9-270f19fc90152013-03-15WarningsExact identifier
spl id: d0a8f2c8-a3d5-4cac-b9bf-c4d8df7e2485
spl set id: 732cd28f-36c2-482c-87a9-270f19fc9015

Reported adverse events (FAERS/openFDA)#

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