Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43
Route
ORAL
Published
Effective Date 2024-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Acesulfame Potassium Carboxymethylcellulose Sodium Cellulose, Microcrystalline Anhydrous Citric Acid Glycerin High Fructose Corn Syrup Water D&c Red No. 33 Fd&c Red No. 40 Sodium Benzoate Sorbitol Xanthan Gum Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-31

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant


Medication Information

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg

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

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Warnings

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.

Directions
  • 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 4 do not use
Do Not Use
  • 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.
Package Label
DOLLAR GENERAL HEALTH Children's Plus Cough & Runny Nose
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

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?

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredients of Children's Tylenol® Plus Cough & Runny Nose*

For Ages 6 to 11 Years

Children's

Plus Cough & Runny Nose

Acetaminophen

Chlorpheniramine maleate

Dextromethorphan HBr

Oral Suspension

Pain reliever/fever reducer

Antihistamine

Cough suppressant

ALCOHOL 0.02%

Relieves cough, runny nose, sneezing, fever, sore throat

Cherry Flavor

FL OZ (mL)

Dosage Cup Provided

*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 OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

When Using This Product
  • 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
  • new symptoms occur
  • redness or swelling is present
  • pain or cough gets worse or lasts for more than 5 days
  • fever gets worse or lasts more than 3 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.

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 for adults as well as children 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

Ask A Doctor Before Use If the Child Has
  • 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
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Structured Label Content

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

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Warnings

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.

Directions
  • 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 4 do not use
Do Not Use (Do not use)
  • 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.
Package Label
DOLLAR GENERAL HEALTH Children's Plus Cough & Runny Nose
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredients of Children's Tylenol® Plus Cough & Runny Nose*

For Ages 6 to 11 Years

Children's

Plus Cough & Runny Nose

Acetaminophen

Chlorpheniramine maleate

Dextromethorphan HBr

Oral Suspension

Pain reliever/fever reducer

Antihistamine

Cough suppressant

ALCOHOL 0.02%

Relieves cough, runny nose, sneezing, fever, sore throat

Cherry Flavor

FL OZ (mL)

Dosage Cup Provided

*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 OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

When Using This Product (When using this product)
  • 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 (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain or cough gets worse or lasts for more than 5 days
  • fever gets worse or lasts more than 3 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. (Keep out of reach of children.)

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 for adults as well as children 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

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • 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 (Ask a doctor or pharmacist before use if the child is taking)
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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