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

Childrens Cold, Cough and Sore Throat by

Drug Labeling and Warnings

Childrens Cold, Cough and Sore Throat by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-518
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 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	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE (Blue to Bluish Green)	Score
Shape		Size
Flavor	BERRY, MANGO, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-518-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/03/2016

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-518)