Label: GUAIFENESIN AND CODEINE PHOSPHATE SF- guaifenesin and codeine phosphate liquid
Contains inactivated NDC Code(s)
NDC Code(s): 54868-4768-0, 54868-4768-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0603-1075
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- 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 February 13, 2012
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- Active ingredients (in each 5 mL = 1 tsp)
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- 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 liquid
Product 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