NDC | 58602-514-20 |
Set ID | 9b25af98-d826-4a45-80b2-ae447b1fe2ed |
Category | Human OTC Drug Label |
Packager | Aurohealth 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
- Ask a doctor or pharmacist before use if you are
- When using this product do not use more than directed
- 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 or Comments
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)
NDC 58602-514-20
Primary Health
Compare to Adult Robitussin®
Peak Cold Multi-Symptom Cold
Active ingredients*
ADULT
Tussin
PEAK COLD
Multi-Symptom Cold
Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP (Expectorant)
10 mg- Phenylephrine HCl, USP (Nasal Decongestant)
Relieves:- Cough
- Nasal Congestion
- Mucus
- For Ages 12 & Over
Raspberry Flavor
Non-Drowsy
8 FL OZ(237 mL) -
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)
NDC 58602-514-20
Primary Health
Compare to Adult Robitussin®
Peak Cold Multi-Symptom Cold
Active ingredients*
ADULT
Tussin
PEAK COLD
Multi-Symptom Cold
Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP (Expectorant)
10 mg- Phenylephrine HCl, USP (Nasal Decongestant)
Relieves:- Cough
- Nasal Congestion
- Mucus
- For Ages 12 & Over
Rasberry Flavor
Non-Drowsy
8 FL OZ(237 mL) -
INGREDIENTS AND APPEARANCE
ADULT TUSSIN PEAK COLD MULTI-SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-514 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) RASPBERRY (UNII: 4N14V5R27W) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (a clear red co lo red liquid) Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-514-20 1 in 1 CARTON 09/25/2018 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 09/25/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-514)