999 COLD REMEDY GRANULAR- acetaminophen, chlorpheniramine maleate granule

999 COLD REMEDY GRANULAR by

Drug Labeling and Warnings

999 COLD REMEDY GRANULAR by is a Otc medication manufactured, distributed, or labeled by China Resources Sanjiu Medical & Pharmaceutical Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Acetaminophen                     200 mg

Chlorpheniramine Maleate        4 mg

Purpose

Acetaminophen                          Pain Reliever/Fever Reducer

Chlorpheniramine Maleate         Antihistamine

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

Warnings

Do not use if

pain lasts more than 10 days

fever lasts more than 3 days

Ask a doctor before using if you have

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

Taking sedatives or transquilizers

When using this product

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

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

If pregnant or beasting-feeding, ask a health professional before using.

Stop use and consult a doctor

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

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

Protect from light and excessive heat

Keep tightly closed

Keep in a dry place

Other Ingredients

Caffeine

Melicope Pteleifolia Leaf

Bidens Pilosa

Dendranthema Indicum Flower

Ilex Peduunculosa Whole

Drug Facts

INGREDIENTS AND APPEARANCE

999 COLD REMEDY GRANULAR 
acetaminophen, chlorpheniramine maleate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12753-307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	200 mg  in 90 g
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	Chlorpheniramine Maleate	4 mg  in 90 g

Inactive Ingredients
Ingredient Name	Strength
Caffeine (UNII: 3G6A5W338E)
MELICOPE PTELEIFOLIA LEAF (UNII: 1I20C6Y98I)
Bidens Pilosa Whole (UNII: AYT02NS64S)
Dendranthema indicum flower (UNII: I6OER6U04L)
ilex Pedunculosa whole (UNII: 46804GL8SN)

Product Characteristics
Color	white	Score	2 pieces
Shape	SQUARE	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12753-307-02	10 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/03/2003

Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)

Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)

Establishment
Name	Address	ID/FEI	Business Operations
China Resources Sanjiu Medical & Pharmaceutical Co Ltd		544695711	manufacture(12753-307)