999 GANMAOLING COLD- acetaminophen caffeine chlorpheniramine maleate capsule

999 GANMAOLING by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Acetaminophen 100 mg
Caffeine 2 mg
Chlorpheniramine Maleate 2 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Pain reliever aid

Antihistamine

INDICATIONS & USAGE

Uses  Temporarily relieves the following symptoms associated with the common cold, hay fever or other upper respiratory allergies: Minor aches an pains Headache Sneezing Muscular aches Itchy, watery eyes Runny nose Sore Throat Itching of the nose or throat Fever

WARNINGS

Warnings

Liver warningThis product contains acetaminophen, Severe liver damage many occur if you take ■ more than 6 packets in 24 hours, which is the maximum daily amount for this product ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are ■have liver disease ■are taking sedatives or tranquilizers ■ are taking the blood thinner drug, warfarin

WHEN USING

When using this product ■ May cause excitability, especially in children ■ May cause drowsiness, if used with alcohol, sedatives, or tranquilizers ■ Use caution when driving a motor vehicle or operating machinery.

STOP USE

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 ■ Fever lasts more than 3 days ■ If new symptoms occur such as rash, nausea or vomiting.

KEEP OUT OF REACH OF CHILDREN

If pregnant or breast-feeding ask a health professional before using.
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 of symptoms. Do not exceed recommended

DOSAGE & ADMINISTRATION

Directions■ Adults and children 12 years of age and older: Take 2 capsules 3 times a day. Do not exceed 12 capsules in 24 hours.
■ Children under 12 years of age: Consult a doctor before using.

SPL UNCLASSIFIED SECTION

Other Information
■ Protect form light and excessive heat ■ Keep tightly closed ■ Keep in dry place

INACTIVE INGREDIENT

Other Ingredients
Chrysanthemum (flower), Evodia (unripe fruit), Roughhaired Holly (root), Spanish needles, Peppermint oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

999 GANMAOLING  COLD
acetaminophen caffeine chlorpheniramine maleate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63922-601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	100 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	2 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)
ILEX PUBESCENS ROOT (UNII: V5V22LFX73)
BIDENS BIPINNATA WHOLE (UNII: TRQ4JQ7DJQ)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	white (clear)	Score	2 pieces
Shape	CAPSULE (Capsule)	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63922-601-01	1 in 1 BOX
1	NDC: 63922-601-12	12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/30/2012

Labeler - Kingsway (780573205)

Establishment
Name	Address	ID/FEI	Business Operations
China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd		544695711	manufacture