NDC | 58602-108-24 |
Set ID | 79ec8f43-b48f-437b-87a8-2b1ab1d978b0 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Purposes
- Uses
-
Warnings
Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Avoid foods or beverages that contain caffeine. - Ask a doctor before use if the child has
- Do not exceed recommended dosage.
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- measure only with dosing cup provided
- do not use dosing cup with other products
- mL= milliliter; tsp = teaspoon
Age Dose Children 4 years to 6 years 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours Children 6 years to 12 years 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours Children under 4 years do not use unless directed by a doctor - Other information
- Inactive ingredients
- Questions or Comments?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)
AUROHEALTH
NDC 58602-108-24
Compare to the
active ingredients in
Children’s Mucinex®
Stuffy Nose & Cold*
AuroMucus
Children's
Stuffy Nose and Cold
Each dose 5 mL (1 tsp) of oral solution contains:
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 2.5 mgExpectorant
Nasal decongestant
• Stuffy Nose
• Chest congestion
• Breaks up mucus
DOSING CUP
INCLUDED
Alcohol-freeFor Ages 4+
Mixed Berry
Flavor Syrup4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
AUROMUCUS - CHILDRENS STUFFY NOSE AND COLD
guaifenesin and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 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) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) MANGO (UNII: I629I3NR86) PINEAPPLE (UNII: 2A88ZO081O) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (Pink to Red) Score Shape Size Flavor BERRY, MANGO, PINEAPPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-108-24 1 in 1 CARTON 05/19/2015 05/01/2022 1 118 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 05/19/2015 05/01/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-108)