Label: TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 58809-216-08
- Packager: GM Pharmaceuticals, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 15 mL)
- Purpose
- Uses
-
WARNINGS
Do not exceed recommended dosage.
Do not use
in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- persistent or chronic cough such as occurs with asthma
- a cough that occurs with too much phlegm (mucus)
- a sodium-restricted diet
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
TexaClear Kids Daytime Cough and Chest Congestion
NDC 58809-216-08
8 fl. oz. (237 mL)Dextromethorphan HBR – Cough Suppressant
Guaifenesin – ExpectorantTamper evident: do not use if foil seal under cap is broken on missing
- Dye Free
- Sugar Free
- Gluten Free
- Alcohol Free
- Acetaminophen Free
Ages 4+
Relieves:
- Chest Congestion
- Thins & Loosens Mucus
- Cough
Distributed by:
GM Pharmaceuticals, Inc. Fort Worth, TX 76118 -
INGREDIENTS AND APPEARANCE
TEXACLEAR KIDS DAYTIME COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-216 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-216-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/25/2023 Labeler - GM Pharmaceuticals, INC (793000860)