NDC | 0031-8716-12 |
Set ID | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd |
Category | HUMAN OTC DRUG LABEL |
Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 10 ml)
- Purposes
- Uses
-
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- 1.
- heart disease
- 2.
- high blood pressure
- 3.
- thyroid disease
- 4.
- diabetes
- 5.
- trouble urinating due to an enlarged prostate gland
- 6.
- cough that occurs with too much phlegm (mucus)
- 7.
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
-
Directions
- 1.
- measure only with dosing cup provided
- 2.
- keep dosing cup with product
- 3.
- ml = milliliter
- 4.
- do not take more than 6 doses in any 24-hour period
age dose children under 4 years
do not use
children 4 to under 6 years
5 ml every 4 hours
children 6 to under 12 years
10 ml every 4 hours
adults and children 12 years and over
20 ml every 4 hours
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHILDRENS ROBITUSSIN COUGH AND COLD CF
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8716 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 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (clear red) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8716-12 1 in 1 CARTON 09/01/2009 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2009 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)