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999 COLD REMEDY GRANULAR

Dosage form: granule
Ingredients: Acetaminophen 200mg in 90g, Chlorpheniramine Maleate 4mg in 90g
Labeler: China Resources Sanjiu Medical & Pharmaceutical Co Ltd
NDC Code: 12753-307

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

999 COLD REMEDY GRANULAR

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

999 COLD REMEDY GRANULAR 
acetaminophen, chlorpheniramine maleate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12753-307
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (ACETAMINOPHEN) Acetaminophen200 mg  in 90 g
Chlorpheniramine Maleate (CHLORPHENIRAMINE) Chlorpheniramine Maleate4 mg  in 90 g
Inactive Ingredients
Ingredient NameStrength
Caffeine 
MELICOPE PTELEIFOLIA LEAF 
Bidens Pilosa Whole 
Dendranthema indicum flower 
ilex Pedunculosa whole 
Product Characteristics
ColorwhiteScore2 pieces
ShapeSQUARESize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:12753-307-0210 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/03/2003
Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)
Establishment
NameAddressID/FEIOperations
China Resources Sanjiu Medical & Pharmaceutical Co Ltd544695711manufacture(12753-307)

Revised: 09/2013
 
China Resources Sanjiu Medical & Pharmaceutical Co Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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