NDC | 63922-605-01, 63922-605-12 |
Set ID | 0a205049-811f-4f66-ac29-cb2a7b4efbf0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Kingsway |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- 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)