Label: 999 GANMAOLING COLD- acetaminophen caffeine chlorpheniramine maleate capsule
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 3, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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 DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
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
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- 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