Active Ingredients And Purpose
Active ingredients (in each 10 mL)
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purposes
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Cough Cold and Sore Throat
- Manufacturer
- Walgreens
- Effective date
- 2024-05-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:13
Key Label Information#
Uses
Uses
temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion stuffy nose sore throat minor aches and pains 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
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: skin reddening blisters rash If a 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.
Directions And Dosage
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 last do not give more than 5 days unless directed by a doctor keep dosing cup with product use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. dose as follows, or as directed by a doctor mL=milliliter children 6 to under 12 years of age : 10 mL in dosing cup provided children under 6 years of age : do not use
Other Label Information
Other information
each 10 mL contains : sodium 6 mg store between 20-25º C (68-77ºF). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Cold, Cough & Sore Throat†† Children's Cold, Cough & 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 Relief from cough, sore throat, stuffy nose & chest congestion Breaks up mucus AGES 6 - 11 YEARS FL OZ (mL) Berry flavor ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 8 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 8 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 8 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 8 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 8 |
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 |
|---|---|---|---|---|---|---|
| 0363-4050-04 | Cough Cold and Sore ThroatChildrens | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 8 | |
| 0363-4050-04 | Cough Cold and Sore ThroatChildrens | 1 in 1 BOX | LIQUID | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-4050 | COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240509_400a0998-e276-4c8d-9b41-145b1b405fff.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-4050-04 | ML - Milliliter | 0363-4050 | e34cb092-14f3-401f-abc7-b542d6e84adb | 1 | 2018-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Products#
- Cough Cold and Sore Throat Childrens
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- DEXTROMETHORPHAN
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-4050 | 0363-4050-04 |
Ingredients#
Complete SPL Sections#
Active ingredients (in each 10 mL)
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purposes
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion stuffy nose sore throat minor aches and pains 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 Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a 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.
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 last do not give more than 5 days unless directed by a doctor keep dosing cup with product use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. dose as follows, or as directed by a doctor mL=milliliter 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 store between 20-25º C (68-77ºF). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Cold, Cough & Sore Throat†† Children's Cold, Cough & 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 Relief from cough, sore throat, stuffy nose & chest congestion Breaks up mucus AGES 6 - 11 YEARS FL OZ (mL) Berry flavor ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Package Label
WALGREENS Children's Cold, Cough, and Sore Throat Berry Flavor