Children’s Multi-symptom Fever & Cold 4 Fl Oz (118 Ml) Grape Flavor

Children’s Multi-symptom Fever & Cold 4 Fl Oz (118 Ml) Grape Flavor
SPL v6
SPL
SPL Set ID 3daf7620-eb57-43d5-ba88-938b7221e346
Route
ORAL
Published
Effective Date 2020-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid 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 Carboxymethylcellulose Sodium, Unspecified Sorbitol Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-03

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Uses
  • temporarily relieves
    • minor aches and pains
    • headache
    • minor sore throat pain
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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
  • shake well before use
  • may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.
  • mL = milliliter

Age

Dose

children under 4 years

do not use

children 4 to under 6 years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

10 mL

Do Not Use
  • in a child under 4 years of age
  • if your child is allergic to acetaminophen
  • 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 taking this product.
  • for the purpose of making your child sleepy
Other Information
  • each 5 mL contains: sodium 5 mg
  • Tamper–evident: do not use if printed inner seal under cap is torn or missing
  • store at room temperature. Protect from light.
  • contains no aspirin
  • close cap tightly
Inactive Ingredients

citric acid, D&C Red #33, edetate disodium, FD&C Blue #1, FD&C Red #40, flavor, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 30142-988-04

Compare to the active ingredients in Children’s Triaminic ®Suspension Multi-Symptom Fever & Cold*

Children’s Multi-Symptom

Fever & Cold

ACETAMINOPHEN /

Pain Reliever/Fever Reliever

CHLORPHENIRAMINE MALEATE /

Antihistamine

DEXTROMETHORPHAN HBR /

Cough Suppressant

PHENYLEPHRINE HCL /

Nasal Decongestant

  • Cold & Flu Symptoms Relief
  • Fever
  • Runny & Stuffy Nose
  • Aches & Pains
  • Sore Throat
  • Cough

Grape Flavor

Ages 6-11 Years

Naturally and artificially flavored

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Children’s Triaminic Suspension Multi-Symptom Fever & Cold.

Distributed by:

When Using This Product
  • do not exceed recommended dosage
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 5 Ml)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, such as occurs with asthma
Ask A Doctor Or Pharmacist Before Use If the Child Is
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves
    • minor aches and pains
    • headache
    • minor sore throat pain
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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
  • shake well before use
  • may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.
  • mL = milliliter

Age

Dose

children under 4 years

do not use

children 4 to under 6 years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

10 mL

Do Not Use (Do not use)
  • in a child under 4 years of age
  • if your child is allergic to acetaminophen
  • 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 taking this product.
  • for the purpose of making your child sleepy
Other Information (Other information)
  • each 5 mL contains: sodium 5 mg
  • Tamper–evident: do not use if printed inner seal under cap is torn or missing
  • store at room temperature. Protect from light.
  • contains no aspirin
  • close cap tightly
Inactive Ingredients (Inactive ingredients)

citric acid, D&C Red #33, edetate disodium, FD&C Blue #1, FD&C Red #40, flavor, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 30142-988-04

Compare to the active ingredients in Children’s Triaminic ®Suspension Multi-Symptom Fever & Cold*

Children’s Multi-Symptom

Fever & Cold

ACETAMINOPHEN /

Pain Reliever/Fever Reliever

CHLORPHENIRAMINE MALEATE /

Antihistamine

DEXTROMETHORPHAN HBR /

Cough Suppressant

PHENYLEPHRINE HCL /

Nasal Decongestant

  • Cold & Flu Symptoms Relief
  • Fever
  • Runny & Stuffy Nose
  • Aches & Pains
  • Sore Throat
  • Cough

Grape Flavor

Ages 6-11 Years

Naturally and artificially flavored

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Children’s Triaminic Suspension Multi-Symptom Fever & Cold.

Distributed by:

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • 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)
  • 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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, such as occurs with asthma
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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