NDC | 54868-4768-0, 54868-4768-1 |
Set ID | 5b426e6a-b892-4ed9-afee-06d5a8af6320 |
Category | HUMAN OTC DRUG LABEL |
Packager | Physicians Total Care, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 5 mL = 1 tsp)
- Purpose
- Uses
- Warnings
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
-
Directions
- take every 4 hours
- do not take more than 6 doses in any 24-hour period
adults and children 12 years and over
take 10 mL (2 tsp)
children 6 years to under 12 years
take 5 mL (1 tsp)
children 2 years to under 6 years
consult a doctor
children under 2 years
do not use
Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND CODEINE PHOSPHATE SF
guaifenesin and codeine phosphate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-4768(NDC:0603-1075) Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CARAMEL (UNII: T9D99G2B1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4768-0 118 mL in 1 BOTTLE, PLASTIC 2 NDC:54868-4768-1 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/26/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel