Children’S Daytime Cold & Cough Active Ingredients (In Each 10 Ml)
Brompheniramine maleate, 2 mg
Dextromethorphan HBr, 10 mg
Phenylephrine HCl, 5 mg
Target Childrens Dt And Nt Cold And Cough Kit
FDA Label NDC 82442-536
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Target Childrens Dt And Nt Cold And Cough (NDC 82442-536). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding children’s daytime cold & cough active ingredients (in each 10 ml), children’s nighttimecold & congestionactive ingredients (in each 10 ml), purposes forchildren’s daytime cold & cough, purposes forchildren’s nighttimecold & congestion, uses, warnings do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Children’S Nighttimecold & Congestionactive Ingredients (In Each 10 Ml)
Diphenhydramine HCL12.5 mg
Phenylephrine HCL5 mg
Purposes Forchildren’S Daytime Cold & Cough
Antihistamine
Cough suppressant
Nasal decongestant
Purposes Forchildren’S Nighttimecold & Congestion
Antihistamine/Cough suppressant
Nasal decongestant
Uses
Daytime
- temporarily relieves
- nasal congestion
- runny nose
- cough
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily restores freer breathing through the nose.
- temporarily relieves
- nasal congestion
- runny nose
- cough
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily restores freer breathing through the nose.
Nighttime
Warnings Do Not Use
Daytime
- to sedate a child or to make a child sleepy
- if you are now 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.
- to sedate a child or to make a child sleepy
- if you are now 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 product containing diphenhydramine, even one used on skin
Nighttime only
Ask A Doctor Before Use If You Have
DAYTIME
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
NIGHTTIME
When Using This Product
Daytime
- do not use more than directed.
- may cause marked drowsiness
- avoid alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- do not use more than directed.
- may cause marked drowsiness
- avoid alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Nighttime
Stop Use And Ask A Doctor If
DAYTIME
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better with 7 days or are accompanied with fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache.
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better with 7 days or are accompanied with fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache.
These could be signs of a serious condition.
NIGHTTIME
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Daytime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Nighttime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
If Pregnant Or Breast-Feeding,
Ask a health professional before use
Directions
Daytime
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided.
- Keep dosage cup with product
- mL= milliliter
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided.
- Keep dosage cup with product
- mL= milliliter
age | dose |
Adults and children 12 years and over | 20 mL every 4 hours |
children 6 to under 12 years | 10 mL every 4 hours |
children under 6 years of age | do not use |
Nighttime
age | dose |
Adults and children 12 years and over | 20 mL every 4 hours |
children 6 to under 12 years | 10 mL every 4 hours |
children under 6 years of age | do not use |
Other Information
Daytime
- each 10 mL contains:sodium 6 mg
- store at room temperature.
- each 10 mL contains:sodium 6 mg
- store at room temperature.
Nighttime
Inactive Ingredients
Inactive ingredients for Day Time
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Inactive ingredients for Nighttime
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Children's Dimetapp® Cold & Cough*
Children's Daytime
Cold & Cough
Brompheniramine Maleate 2 mg (Antihistamine),
Dextromethorphan HBr 10 mg (Cough Suppressant)
Phenylephrine HCI 5 mg (Nasal Decongestant)
- Sneezing, stuffy or runny nose, cough, itchy or watery eyes
- No added alcohol
- Sneezing, stuffy or runny nose, cough, itchy or watery eyes
- No added alcohol
Dosing Cup Included
Ages 6+ Years
Grape Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
4 FL OZ (118mL)
Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**
Children's Nighttime
Cold & Congestion
Diphenhydramine HCI 12.5 mg (Antihistamine / Cough Suppressant)
Phenylephrine HCI 5 mg (Nasal Decongestant)
Dosing Cup Included
Ages 6+ Years
Grape Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
4 FL OZ (118mL)
8 FL OZ (236 mL) TOTAL
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. ALWAYS WAIT AT LEAST 4 HOURS BEFORE TAKING ANOTHER DOSE OF THE PRODUCT.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
IMPORTANT:KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING
*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Cold & Congestion.
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Distributed by: Target Corporation
Minneapolis, MN 55403
Made in the U.S.A. with domestic and imported ingredients
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