Childrens Cold, Cough and Sore Throat

Manufacturer
Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:03:58

Label at a glance#

ProductChildrens Cold, Cough and Sore Throat
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and 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...

Dosage and administration

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...

Storage and handling

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.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

your child is taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed (see Overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-51858602-518-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
565ca4bb-9c3a-481d-a9fd-521c9a6c5d39d349e37f-bb74-4b49-bff9-e1c58d204d5e2020-11-26WarningsExact identifier
spl id: 565ca4bb-9c3a-481d-a9fd-521c9a6c5d39
spl set id: d349e37f-bb74-4b49-bff9-e1c58d204d5e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.