Childrens Multi-symptom Cold and Fever Liquid

Manufacturer
Wal-Mart Stores, Inc.
Effective date
2018-01-08
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:29

Label at a glance#

ProductChildrens Multi-symptom Cold and Fever Liquid
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) shake well before use 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 measure only with dosing cup provided do not use dosing cup with other products dose as follows or ...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenyephrine HCl 5 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

USE(S)

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:

  • nasal congestion 
  • stuffy nose
  • cough due to minor throat and bronchial irritation
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

WARNINGS

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes 


  • more than 5 doses in 24 hous, 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. 

DO NOT USE

OTC - DO NOT USE SECTION

  • 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 THE CHILD HAS

OTC - ASK DOCTOR SECTION

  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • your child is taking the blood thinning drug warfarin

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not use more than directed

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN 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 even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • shake well before use
  • 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
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Children 6 to under 12 years of age: 10 mL in dosing cup provided.
  • mL = milliliter
  • Children under 6 years of age: do not use.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.


QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-772-03

equate

Compare to Children's Mucinex®Multi-Symptom Cold & Fever active ingredients*

Children's Multi-Symptom Cold & Fever Liquid

Acetaminophen 325 mg
Pain reliever/Fever Reducer

Dextromethorphan HBr 10 mg

Cough Suppressant
Guaifenesin 200 mg

Expectorant
Phenylephrine HCl 5 mg

Nasal Decongestant

AGES 6 to 12 YEARS



  • Relieves nasal and chest congestion
  • Soothes Cough 
  • Reduces fever
  • Thins and loosens Mucus
  • Alcohol Free
  • Berry Burst Flavored 

4 FL OZ (118 mL)
772772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593450acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SuspensionPSN1
1593450acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD1
1593450acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SuspensionSY1
1593450acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SuspensionSY1
1593450APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-772-03Childrens Multi-symptom Cold and Fever Liquid1 in 1 CARTONLIQUID11
49035-772-03Childrens Multi-symptom Cold and Fever Liquid118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-772CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WAL-MART STORES, INC.]1Current NDC, Legacy NDC, 2 package rows20180801_7bf30c75-e867-4a2f-a481-702d7aa96c23.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-77249035-772-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
ndc (package): 49035-772-03
ndc (product): 49035-772
ndc11 (package): 49035077203
spl id: 7bf30c75-e867-4a2f-a481-702d7aa96c23
spl set id: 7bf30c75-e867-4a2f-a481-702d7aa96c23

Reported adverse events (FAERS/openFDA)#

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