NDC | 68998-528-20 |
Set ID | 3b81d6be-7014-4d9a-80ff-3296fd0478a4 |
Category | Human OTC Drug Label |
Packager | Marc Glassman, Inc. |
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
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- do not take more than 6 doses (12 tsp) in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- this adult product is not intended for use in children under 12 years of age
Age Dose adults and children
12 years and over10 mL
every 4 hourschildren under 12 years do not use - Other information
- Inactive ingredients
- QUESTIONS
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle) Label
NDC 68998-528-20
Compare to the active ingredients in
Adult Robitussin® Peak Cold
Muti-Symptom Cold
Marcs®
adult
Tussin CF
MULTI-SYMPTOM COLD
Dextromethorphan HBr
(Cough Suppressant)
Guaifenesin
(Expectorant)
Phenylephrine HCl
(Nasal Decongestant)
For Relief of:- Cough
- Nasal Congestion
- Mucus
- For Ages 12 & Over
- Non-Drowsy
- Berry Flavor
8 FL OZ (237 mL)
-
INGREDIENTS AND APPEARANCE
ADULT TUSSIN CF MULTI-SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-528 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) LEVOMENTHOL (UNII: BZ1R15MTK7) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) BERRY (UNII: FV3431923Z) Product Characteristics Color RED (a clear red colored liquid) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-528-20 1 in 1 CARTON 07/14/2017 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/14/2017 Labeler - Marc Glassman, Inc. (094487477) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(68998-528)