Topcare Children's Cold & Cough & Runny Nose Relief

Topcare Children's Cold & Cough & Runny Nose Relief
SPL v2
SPL
SPL Set ID 8931d4ca-c599-49be-87e1-8c0598f38b77
Route
ORAL
Published
Effective Date 2024-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1 mg) Dextromethorphan (5 mg) Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified D&c Red No. 33 Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Microcrystalline Cellulose Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-12

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • sneezing and runny nose
    • cough
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1
Active ingredients (in each 5 mL) Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Chlorpheniramine maleate 1 mg

Antihistamine

Dextromethorphan HBr 5 mg

Cough suppressant

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning )
  • shake well before using
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours, while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)

under 36

under 4 years

do not use

36-47

4 to 5 years

do not use unless directed by a doctor

48-95

6 to 11 years

10 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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.
  • 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.
  • if your child has ever had an allergic reaction to this product or any of its ingredients
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
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • each 5 mL contains:sodium 3 mg
  • store at room temperature

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

Inactive Ingredients

citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S TYLENOL® COLD + COUGH + RUNNY NOSE*

NDC 76162-792-04

Children's

Cold & Cough & Runny Nose Relief

ORAL SUSPENSION

ACETAMINOPHEN -PAIN RELIEVER-FEVER REDUCER

CHLORPHENIRAMINE MALEATE -ANTIHISTAMINE

DEXTROMETHORPHAN HBR -COUGH SUPPRESSANT

RELIEVES

  • Fever
  • Sore Throat
  • Sneezing
  • Runny Nose
  • Cough

GRAPE FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

Ages 6-11 Years

4 FL OZ (120 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAT UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ®Cold + Cough + Runny Nose.

When Using This Product
  • do not exceed recommended dose (see overdose warning )
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has
  • liver disease
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • 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
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • sneezing and runny nose
    • cough
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL) Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Chlorpheniramine maleate 1 mg

Antihistamine

Dextromethorphan HBr 5 mg

Cough suppressant

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning )
  • shake well before using
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours, while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)

under 36

under 4 years

do not use

36-47

4 to 5 years

do not use unless directed by a doctor

48-95

6 to 11 years

10 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Do Not Use (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.
  • 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.
  • if your child has ever had an allergic reaction to this product or any of its ingredients
Liver Warning (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
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each 5 mL contains:sodium 3 mg
  • store at room temperature

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

Inactive Ingredients (Inactive ingredients)

citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S TYLENOL® COLD + COUGH + RUNNY NOSE*

NDC 76162-792-04

Children's

Cold & Cough & Runny Nose Relief

ORAL SUSPENSION

ACETAMINOPHEN -PAIN RELIEVER-FEVER REDUCER

CHLORPHENIRAMINE MALEATE -ANTIHISTAMINE

DEXTROMETHORPHAN HBR -COUGH SUPPRESSANT

RELIEVES

  • Fever
  • Sore Throat
  • Sneezing
  • Runny Nose
  • Cough

GRAPE FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

Ages 6-11 Years

4 FL OZ (120 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAT UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ®Cold + Cough + Runny Nose.

When Using This Product (When using this product)
  • do not exceed recommended dose (see overdose warning )
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
  • liver disease
  • a breathing problem such as chronic bronchitis
  • glaucoma
  • 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 (Ask a doctor or pharmacist before use if your child is)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)