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#
Contacts and useful links#
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
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
res
Products#
Every source-derived product name is available through these pages.
- Childrens Mucus Relief Cough, Cold and Sore Throat
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- PROPYL GALLATE
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-321 | 76281-321-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3aedc93a-aadf-441d-ba3f-b4a0c125281e | fed91de5-baf5-4acd-b200-6cd2386c8775 | 2023-12-30 | Warnings | fed91de5-baf5-4acd-b200-6cd2386c8775 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

