999 COLD REMEDY- acetaminophen, chlorpheniramine maleate, caffeine capsule

999 COLD REMEDY by

Drug Labeling and Warnings

999 COLD REMEDY 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 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

INGREDIENTS AND APPEARANCE

999 COLD REMEDY 
acetaminophen, chlorpheniramine maleate, caffeine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12753-305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	100 mg  in 6000 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 6000 mg

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	OVAL	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12753-305-01	6000 mg in 1 CARTON

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(12753-305)