FDA.reportPublic FDA data

Childrens Plus Cough and Runny Nose

Manufacturer
Freds Inc
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:19:51

Label at a glance#

ProductChildrens Plus Cough and Runny Nose
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat  cough sneezing and runny nose headache temporarily reduces fever

Dosage and administration

this product does not contain directions or complete warnings for adult use. mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age...

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • sore throat 
    • cough
    • sneezing and runny nose
    • headache
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount
  • with other drugs contaning 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

  • to make a child sleepy
  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if the child is taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose (see overdose warning )
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • pain or cough gets worse or lasts for more than 5 days
  • 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 (1-800-222-1222) 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.
  • mL = milliliter
  • shake well before using
  • do not give more than 5 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • if needed, repeat dose every 4 hours while symptoms last
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb)Age (yr)Dose (mL)
 48-95 6-11 10 mL
 36-47 4-5 do not use unless directed by a doctor
 under 36 under 4do not use

Other Information

SPL UNCLASSIFIED SECTION

  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare To Active Ingredients in Children's Tylenol® Plus Cough & Runny Nose

Children's Plus COUGH & RUNNY NOSE

Pain Reliever, Fever Reducer,

Cough Suppressant, Antihistamine

RELIEVES:

  • Fever & Sore Throat

Acetaminophen

  • Sneezing & Runny Nose

Chlorpheniramine Maleate

  • Cough

Dextromethorphan HBr

Alcohol 0.005%

Oral Suspension

FOR AGES 6 TO 11 YEARS

FL OZ (mL)

CHERRY

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP  IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS,TN 38118

www.fredsinc.com

Questions or comments: 1855-331-FRED (3733)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRED'S Children's Plus Cough & Runny Nose Cherry Flavor
FRED'S Children's Plus Cough & Runny Nose Cherry Flavor

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
55315-29755315-297-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MIACT

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
a22b8980-ef51-471f-bef6-fee013b9bbdf2e2f3a59-8c6f-4e9a-bf13-75725324e47d2023-11-28WarningsExact identifier
spl id: a22b8980-ef51-471f-bef6-fee013b9bbdf
spl set id: 2e2f3a59-8c6f-4e9a-bf13-75725324e47d

Reported adverse events (FAERS/openFDA)#

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