CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2024-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:11
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients Purpose
(in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 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 pains • sore throat • headache • fever
• cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skinreddening • 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
• Iiver 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 help 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 a Poison Control Center right away. Quick medical attention is critical for adults as well as for children 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
| 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 IS-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
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Maximum Strength MAX COLD & SINUS
AP SAFE NDC 76281-519-24
Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*
Children's
Cold, Cough
& Sore Throat
Pain reliever/Fever Reducer
Cough Suppresant
Expectorant
Nasal decongestant
For Ages 6 to 12
Mixed Berry Flavor
4 FL OZ ( 118 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
* This product is not manufactured or distributed by Reckitt
Benckiser Inc., distributor ofchildren's Mucinex® Cold,
Cough & Sore Throat liquid.
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1593450 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension | PSN | 2 |
| 1593450 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension | SCD | 2 |
| 1593450 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension | SY | 2 |
| 1593450 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension | SY | 2 |
| 1593450 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-519-24 | CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | 1 in 1 CARTON | LIQUID | 1 | 2 | |
| 76281-519-24 | CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | 118 mL in 1 BOTTLE | LIQUID | 118 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76281-519 | CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.] | 2 | Current NDC, 2 package rows | 20240202_5962a73e-72e4-493b-94a7-43bc6cf9c82f.zip |
Products#
Every source-derived product name is available through these pages.
- CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY
- 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 |
|---|---|
| 76281-519 | 76281-519-24 |
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 | ACTIB |
| 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 |
|---|---|---|---|---|---|---|
| CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 5962a73e-72e4-493b-94a7-43bc6cf9c82f | 2024-02-01 | Warnings | 76281-519-24 76281-519 76281051924 2f25ce5a-4e46-4e77-be6d-041a502a5049 5962a73e-72e4-493b-94a7-43bc6cf9c82f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

