999 COLD REMEDY GRANULAR

Manufacturer
China Resources Sanjiu Medical & Pharmaceutical Co Ltd
Effective date
2013-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2972
Source
full-release
Hydrated at
2026-05-31 22:37:00

Label at a glance#

Product999 COLD REMEDY GRANULAR
Active ingredientAcetaminophen, Chlorpheniramine Maleate
Label structure14 sections

Indications and uses

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies: minor achies and pains headache sneezing musclular aches itchy, watery eyes sore throat running nose fever itching of the nose or throat

Dosage and administration

Adults and children 12 years of age and older: take a 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                     200 mg

Chlorpheniramine Maleate        4 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen                          Pain Reliever/Fever Reducer

Chlorpheniramine Maleate         Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

minor achies and pains

headache

sneezing

musclular aches

itchy, watery eyes

sore throat

running nose

fever

itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use if

pain lasts more than 10 days

fever lasts more than 3 days

Ask a doctor before using 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

Taking sedatives or tranquilizers

As 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 persists or worsen

if redness or swelling is present

if symptoms last for more than 7 days

if new symptoms occur such as rash, mausea or vomiting

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or beasting-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 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 a 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 a dry place

Other Ingredients

INACTIVE INGREDIENT SECTION

Caffeine

Melicope Pteleifolia Leaf

Bidens Pilosa

Dendranthema Indicum Flower

Ilex Peduunculosa Whole

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

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-136901339913419GTIN-13: 6901339913419
EAN-13: 6901339913419
GTIN storage (14 digits): 06901339913419
carton.jpg

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
12753-307-022019-11-27C16284748780-19855d018-dbc5-cd31-e053-dbdaa90ab51a999 COLD REMEDY GRANULAR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12753-307-02999 COLD REMEDY GRANULAR10 g in 1 PACKETGRANULE102972

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12753-307999 COLD REMEDY GRANULAR (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE) GRANULE [CHINA RESOURCES SANJIU MEDICAL & PHARMACEUTICAL CO LTD]2972Legacy NDC, 1 package rows20130924_b6222155-572a-4d3f-9916-4cd6b65c2b84.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2972
Chlorpheniramine MaleateACTIVE INGREDIENTV1Q0O9OJ9Z2972
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2972
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U2972
Bidens Pilosa WholeINACTIVE INGREDIENTAYT02NS64S2972
CaffeineINACTIVE INGREDIENT3G6A5W338E2972
Dendranthema indicum flowerINACTIVE INGREDIENTI6OER6U04L2972
ilex Pedunculosa wholeINACTIVE INGREDIENT46804GL8SN2972
MELICOPE PTELEIFOLIA LEAFINACTIVE INGREDIENT1I20C6Y98I2972

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
12753-30712753-307-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 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
CaffeineCAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
CaffeineCAFFEINE3G6A5W338ESOLUTION / OPHTHALMIC2 %w/wExact 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
3638fcd4-3721-4e7d-8b1d-14e1d358e13db6222155-572a-4d3f-9916-4cd6b65c2b842013-09-24WarningsExact identifier
spl id: 3638fcd4-3721-4e7d-8b1d-14e1d358e13d
spl set id: b6222155-572a-4d3f-9916-4cd6b65c2b84

Reported adverse events (FAERS/openFDA)#

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