MUCUS RELIEF CHILDRENS- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Mucus Relief by

Drug Labeling and Warnings

Mucus Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • nasal congestion due to a cold
  • the intensity of coughing
  • stuffy nose
  • the impulse to cough to help the child get to sleep

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.

Ask a doctor before use if the child has

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

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• do not take more than 6 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• dose as follows or as directed by a doctor

• Age: Dose
• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: 5 mL every 4 hours
• children under 4 years: do not use

Other information

• each 5 mL contains: sodium 3 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-888-423-0139

Principal display panel

+TopCare®
health

NDC: 76162-057-88

COMPARE TO MUCINEX®
CHILDREN’S MULTI-SYMPTOM COLD
ACTIVE INGREDIENTS*

children's
Multi-Symptom
Cold
Mucus
Relief

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
GUAIFENESIN - EXPECTORANT
PHENYLEPHRINE HCl - NASAL DECONGESTANT

ORAL SOLUTION

Controls Cough
Relieves Chest Congestion
Breaks Up Mucus
Relieves
  Stuffy Nose

Ages 4
to
11 Years

6.8 FL OZ (201 mL)

BERRY
FLAVOR

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO LNKA0923
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

*This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Mucinex® Children’s Multi-Symptom Cold.
50844   ORG022305788

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

TopCare 44-057

INGREDIENTS AND APPEARANCE

MUCUS RELIEF  CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-057-88	1 in 1 CARTON	03/07/2024
1		201 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/07/2024

Labeler - TOPCO ASSOCIATES LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(76162-057) , pack(76162-057)