Label: KGS ALLERGY SOOTHING- acetaminophen chlorpheniramine maleate capsule, delayed release pellets
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Contains inactivated NDC Code(s)
NDC Code(s): 63922-605-01, 63922-605-12 - Packager: Kingsway
- 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.
Drug Label Information
Updated February 26, 2014
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- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Liver warningThis product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
KGS ALLERGY SOOTHING
acetaminophen chlorpheniramine maleate capsule, delayed release pelletsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63922-605 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength CAFFEINE (UNII: 3G6A5W338E) COCHINEAL (UNII: TZ8Z31B35M) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) SUCROSE (UNII: C151H8M554) 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:63922-605-01 1 in 1 BOX 1 NDC:63922-605-12 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/30/2014 Labeler - Kingsway (780573205) Establishment Name Address ID/FEI Business Operations Guangzhou Baiyunshan Guanghua Pharmacy Co.,Ltd. 527226626 manufacture(63922-605)