Childrens Mucus Relief Cough, Cold and Sore Throat

Manufacturer
AptaPharma Inc.
Effective date
2021-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:32

Label at a glance#

ProductChildrens Mucus Relief Cough, Cold and Sore Throat
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCI 5 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen  ......................Pain reliever/fever reducer
Dextromethorphan HBr ...................... Cough suppressant
Guaifenesin....... ....................................... Expectorant
Phenylephrine HCI ........................... Nasal decongestant

INDICATIONS & USAGE SECTION

Uses
• temporarily relieves these common cold and flu symptoms:
   • nasal congestion              • stuffy nose
   • minor aches and pain       • sore throat
   • headache                        • fever
   • cough due to minor throat and bronchial irritation
• helps loosed phlegm (mucus) ang thin bronchial
secretions to drain bronchial tubes

WARNINGS SECTION

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
Allery Alert: Acetaminophen may cause severe
skin reactions. Symptoms may include: • skin
reddening • blisters • rash.  If skin reaction
occurs, stop use and seek medical help right away.
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
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• new symptoms occur
• pain, nasal congestion or cough gets worse or lasts
more than 5 days
• fever gets worse or lasts more than 3 days
• cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get
medical heip or contact a Poison Control Center
right away.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions • do not use more than directed
(see overdose warning)
• shake well before using
• do not use more than 5 doses in any 24-hour period
• if needed, repeat dose every 4 hours while symptoms last
• do not use more than 5 days unless directed by a doctor
• use dosage cup

                       Age    Dose
Children 6 to under 12 years of age

10 mL every

4 hours

Children under 6 years of age      do not use

OTHER SAFETY INFORMATION

Other information
• each 10 mL contains: sodium 5 mg
• store between 15-30°C (59-86°F)
• do not refrigerate • dosage cup provided

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions1-877-798-5944

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

Compare to the active
ingredients in Children's
Mucinex® Cold, Cough
& Sore Throat*

NDC 76281-321-24

Children's
Mucus Relief

Cough, Cold

& Sore Throat

Acetaminophen 325 mg
Pain reliever, Fever reducer
Dextromethorphan HBr 10 mg
Cough Suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCI 5 mg
Nasal decongestant

Berry Blast Flavor Liquid

Ages 6+

4 FL OZ (118 mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2021 CVS/pharmacy

CVS.COM

1-800-SHOP-CVS                     BX-127 Rev01

V-37134

*This product is not manufactured or distributed by Reckitt

Benckiser, distributor of Children's Mucinex® Cold, Cough

& Sore Throat.

DO NOT USE IF PRINTED SEAL UNDER CAP

IS TORN OR MISSING

321-24 Box321-24 Box

321-24 Botl321-24 Botl

res

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-32176281-321-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3aedc93a-aadf-441d-ba3f-b4a0c125281efed91de5-baf5-4acd-b200-6cd2386c87752023-12-30WarningsExact identifier
spl set id: fed91de5-baf5-4acd-b200-6cd2386c8775

Reported adverse events (FAERS/openFDA)#

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