FDA.reportPublic FDA data

999 COLD REMEDY CAPSULE

Manufacturer
China Resources Sanjiu Medical & Pharmaceutical Co Ltd
Effective date
2013-09-17
Label type
HUMAN OTC DRUG LABEL
Version
2962
Source
full-release
Hydrated at
2026-05-31 22:36:56

Label at a glance#

Product999 COLD REMEDY
Active ingredientAcetaminophen, CHLORPHENIRAMINE MALEATE
Label structure14 sections

Dosage and administration

Adults and children 12 years of age and older: Take 2 capsules each time, three times a day. Children under 8 years of age: Consult a doctor before using.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 100 mg 

Chlorpheniramine Maleate 2 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen                                    Pain Reliever/Fever Reducer

Chlorpheniramine Maleate                   Antihistamine

Use

INDICATIONS & USAGE SECTION

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

Minor aches and pains

Headache

Itchy, watery eyes

Muscular aches

Sneezing

Runny nose

Sore Throat

Itching of the nose or throat

Fever

Warnings

WARNINGS SECTION

Do not use if

Pain lasts more than 10 days.

Fever lasts more than 3 days

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Glaucoma

A breathing problem such as emphysema or chronic bronchitis

Difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before you use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking sedatives or transquilizers

When using this product

OTC - WHEN USING SECTION

May cause excitability, especially in children

May cause drowsiness, if used with alcohol, sedatives, or transquilizers.

Use caution when driving a motor vehicle or operating machinery.

Stop use and consult a doctor

OTC - STOP USE SECTION

If pain or fever persisits or worsen

If redness or swelling is present

If symptoms last for more than 7 days

If new symptoms occur such as rash, nausea or vomitting.

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

If preganent or breast-feeding, ask a health professional before using.

Stop use and consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 capsules each time, three times a day.

Children under 8 years of age: Consult a doctor before using.

Other Information

OTHER SAFETY INFORMATION

Protect from light and excessive heat

Keep tightly closed

Keep in dry place

Other Ingredients

INACTIVE INGREDIENT SECTION

Cafferine

Melicope Pteleiforlia Leaf

Bidens Pilosa Whole

Dendranthema Indicum Flower

Ilex Pedunculosa Whole

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton.jpgcarton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437775acetaminophen 100 MG / chlorpheniramine maleate 2 MG Oral CapsulePSN2962
1437775acetaminophen 100 MG / chlorpheniramine maleate 2 MG Oral CapsuleSCD2962
1437775APAP 100 MG / Chlorpheniramine Maleate 2 MG Oral CapsuleSY2962

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136901339913211GTIN-13: 6901339913211
EAN-13: 6901339913211
GTIN storage (14 digits): 06901339913211		carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12753-305-012019-11-27C16284748780-19855d018-d3af-cd31-e053-dbdaa90ab51a999 COLD REMEDY CAPSULE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12753-305-01999 COLD REMEDY6000 mg in 1 CARTONCAPSULE60002962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12753-305999 COLD REMEDY (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, CAFFEINE) CAPSULE [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]2962Legacy NDC, 1 package rows20130917_342adb30-c9ee-4973-909e-593ae88829e0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2962
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z2962
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2962
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U2962
Bidens Pilosa WholeINACTIVE INGREDIENTAYT02NS64S2962
CAFFEINEINACTIVE INGREDIENT3G6A5W338E2962
Dendranthema indicum flowerINACTIVE INGREDIENTI6OER6U04L2962
ilex Pedunculosa wholeINACTIVE INGREDIENT46804GL8SN2962
MELICOPE PTELEIFOLIA LEAFINACTIVE INGREDIENT1I20C6Y98I2962

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
12753-30512753-305-01

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
Acetaminophen362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
CAFFEINE3G6A5W338EIACT
MELICOPE PTELEIFOLIA LEAF1I20C6Y98IIACT
Bidens Pilosa WholeAYT02NS64SIACT
Dendranthema indicum flowerI6OER6U04LIACT
ilex Pedunculosa whole46804GL8SNIACT

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CAFFEINECAFFEINE3G6A5W338ESPRAY, METERED / NASAL10 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338ESOLUTION / OPHTHALMIC2 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 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
adbcd49c-e0c4-40d9-8595-41c1b4406dee342adb30-c9ee-4973-909e-593ae88829e02013-09-17WarningsExact identifier
spl id: adbcd49c-e0c4-40d9-8595-41c1b4406dee
spl set id: 342adb30-c9ee-4973-909e-593ae88829e0

Reported adverse events (FAERS/openFDA)#

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