999 COLD REMEDY- acetaminophen, chlorpheniramine maleate, caffeine capsule 
China Resources Sanjiu Medical & Pharmaceutical Co Ltd

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.

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999 COLD REMEDY CAPSULE

Active Ingredients

Acetaminophen 100 mg 

Chlorpheniramine Maleate 2 mg

Purpose

Acetaminophen                                    Pain Reliever/Fever Reducer

Chlorpheniramine Maleate                   Antihistamine

Use

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

Do not use if

Pain lasts more than 10 days.

Fever lasts more than 3 days

Ask a doctor before use if you have

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

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 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

If preganent or breast-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 for children even if you do not notice any signs or symptoms.

Directions

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

Protect from light and excessive heat

Keep tightly closed

Keep in dry place

Other Ingredients

Cafferine

Melicope Pteleiforlia Leaf

Bidens Pilosa Whole

Dendranthema Indicum Flower

Ilex Pedunculosa Whole

Drug Facts

carton.jpg

999 COLD REMEDY 
acetaminophen, chlorpheniramine maleate, caffeine capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12753-305
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen100 mg  in 6000 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 6000 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeOVALSize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12753-305-016000 mg in 1 CARTON
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/FEIBusiness Operations
China Resources Sanjiu Medical & Pharmaceutical Co Ltd544695711manufacture(12753-305)

Revised: 9/2013
Document Id: adbcd49c-e0c4-40d9-8595-41c1b4406dee
Set id: 342adb30-c9ee-4973-909e-593ae88829e0
Version: 2962
Effective Time: 20130917
 
China Resources Sanjiu Medical & Pharmaceutical Co Ltd