Childrens Cold, Cough and Sore Throat

Childrens Cold, Cough and Sore Throat

Drug Labeling and Warnings

Drug Details

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CHILDRENS COLD, COUGH AND SORE THROAT - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution 
Aurohealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Childrens Cold, Cough and Sore Throat

Drug Facts

Active ingredients (in each 10 mL)

Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 200 mg
Phenylephrine HCl, USP 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion 
    • stuffy nose
    • cough due to minor throat and bronchial irritation
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.



Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

Ask a doctor before use if your child has

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

your child is taking the blood thinning drug warfarin

When using this product

do not use more than directed (see Overdose warning)

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.



Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • do not give more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms lasts
  • do not give more than 5 days unless directed by a doctor
  • shake well before using 
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter; tsp = teaspoon
  • children 6 to under 12 years of age: 10 mL in dosing cup provided
  • children under 6 years of age: do not use

Other information

  • each 10 mL contains: sodium 6 mg
  • tamper evident: do not use if printed seal under cap is torn or missing
  • Store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions or Comments?

1-855-274-4122

Distributed by:

Aurohealth LLC.

2572 Brunswick Pike,

Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Container Label)

NDC: 58602-518-24
PrimaryHealth

For Ages 6+
Children's
Cold, Cough, &
Sore Throat

Each dose 10 mL (2 tsp) of
oral solution contains:
Acetaminophen USP 325 mg
(
Pain Reliever/Fever Reducer)
Dextromethorphan HBr USP 10 mg
(Cough Suppressant)
Guaifenesin USP 200 mg
(Expectorant)
Phenylephrine HCl USP 5 mg
(Nasal Decongestant) 


  • Cough
  • Sore Throat
  • Nasal Congestion
  • Chest Congestion

 Fruit
 Flavor Liquid
 4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Container Carton Label)

NDC: 58602-518-24
PrimaryHealth
COMPARE TO Children's Mucinex®
Cold, Cough & Sore Throat
active ingredients*
For Ages 6+
Children's
Cold, Cough, &
Sore Throat


Each dose 10 mL (2 tsp) of
oral solution contains:
Acetaminophen USP 325 mg
(Pain Reliever/Fever Reducer)
Dextromethorphan HBr USP 10 mg
(Cough Suppressant)
Guaifenesin USP 200 mg
(Expectorant)
Phenylephrine HCl USP 5 mg
(Nasal Decongestant) 

  • Cough

  • Sore Throat

  • Nasal Congestion

  • Chest Congestion

DOSING CUP
INCLUDED
 Fruit
 Flavor Liquid
 4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -4 FL OZ (118 mL Container Carton Label)

CHILDRENS COLD, COUGH AND SORE THROAT 
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-518
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
BERRY (UNII: FV3431923Z)  
PINEAPPLE (UNII: 2A88ZO081O)  
MANGO (UNII: I629I3NR86)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBLUE (Blue to Bluish Green) Score    
ShapeSize
FlavorBERRY, MANGO, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-518-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/03/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-518)

Revised: 10/2018
 
Aurohealth LLC


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