999 GANMAOLING COLD- acetaminophen caffeine chlorpheniramine maleate capsule 
Kingsway

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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Drug Facts

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

Purpose

Pain reliever/fever reducer

Pain reliever aid

Antihistamine

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

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 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 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 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 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.

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

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.

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

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

MM1

999 GANMAOLING  COLD
acetaminophen caffeine chlorpheniramine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63922-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN100 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE2 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (clear) Score2 pieces
ShapeCAPSULE (Capsule) Size20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63922-601-011 in 1 BOX
1NDC:63922-601-1212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/30/2012
Labeler - Kingsway (780573205)
Establishment
NameAddressID/FEIBusiness Operations
China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd 544695711manufacture

Revised: 7/2012
Document Id: db0a71dd-c5fa-4580-b085-9895586d953a
Set id: efebbec1-c478-462d-adb9-a01d71a7966f
Version: 1
Effective Time: 20120703
 
Kingsway