FDA Label for Daytime Cold And Cough And Nighttime Cold And Congestion Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 10 ML)
- ACTIVE INGREDIENTS FOR DAYTIME (IN EACH 10 ML)
- PURPOSE FOR NIGHTTIME
- PURPOSE FOR DAYTIME
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THESE PRODUCTS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Cold And Cough And Nighttime Cold And Congestion Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients For Nighttime (In Each 10 Ml)
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Active Ingredients For Daytime (In Each 10 Ml)
Brompheniramine Maleate 2 mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5 mg
Purpose For Nighttime
Antihistamine / Cough suppressant
Nasal Decongestant
Purpose For Daytime
Antihistamine
Cough suppressant
Nasal decongestant
Uses
Nighttime
- temporarily relieves
- nasal congestion
- cough
- runny nose
- sneezing
- itchy, watery eyes due to hay fever
- itching of the nose or throat
- temporarily restores freer breathing through the nose
- temporarily relieves
- nasal congestion
- runny nose
- cough
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- temporarily restores freer breathing through the nose
Daytime
Do Not Use
Nighttime
- 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
- with any other product containing diphenhydramine, even one used on skin.
- to sedate a child or to make 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Daytime
Ask A Doctor Before Use If You Have
Nighttime
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that last as occurs with smoking, asthma, chronic bronchitis or emphysema
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
Daytime
Ask A Doctor Or Pharmacist Before Use If You Are
Nighttime
- taking any other oral nasal decongestant or stimulant
- taking sedative or tranquilizers
- taking any other oral nasal decongestant or stimulant
- taking sedative or tranquilizers
Daytime
When Using These Products
Nighttime
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic drinks
- 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 alcoholic drinks
- alcohol, sedative and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Daytime
Stop Use And Ask A Doctor If
Nighttime
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition
Daytime
If Pregnant Or Breast-Feeding,
Nighttime
ask a health professional before use.
Daytime
ask a health professional before use
Keep Out Of Reach Of Children.
Nighttime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Daytime
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
Nighttime
- do not take more than 6 doses in any 24 hours period
- measure only with dosing cup provided.
- keep dosing cup with product
- mL = milliliter
- do not take more than 6 doses in any 24 hours period
- measure only with dosing cup provided.
- keep dosing 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 | do not use |
Daytime
Age | Dose |
adults and children12 years and over | 20 mL every 4 hours |
children 6 to under 11 years | 10 mL every 4 hours |
Children under 6 years | do not use |
Other Information
Nighttime
- each 10 mL contains: sodium 6 mg
- store at room temperature
- each 10 mL contains: sodium 6 mg
- store at room temperature
Daytime
Inactive Ingredients
Nighttime
citric acid, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose
Daytime
citric acid, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose
Questions Or Comments?
Nighttime
1-866-467-2748
Daytime
1-866-467-2748
Principal Display Panel
Compare to active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**
NDC 82442-647-08
Children's Nighttime
Cold & Congestion
Diphenhydramine HCl (Antihistamine-Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves + comforts:
- stuffy nose, runny nose
- sneezing
- itchy, watery eyes
- cough
- stuffy nose, runny nose
- cough
- itchy, watery eyes
- sneezing
For Ages 6 Years and Over
No Added Alcohol
Grape Flavor
IMPORTANT: Keep this carton for future reference on full labeling
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.
**This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Congestion.
DAYTIME
Compare to active ingredients in Children's Dimetapp® Cold & Cough*
Children's
Cold & Cough
Brompheniramine Maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCI (Nasal Decongestant)
Relieves + comfort
For Ages 6 Years and Over
No Added Alcohol
Grape Flavor
Naturally and artificially Flavored
2 – 4 FL OZ (118 mL) BOTTLES / TOTAL 8 FL OZ (236 mL)
*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Cold & cough
Distributed by
Product Label
* Please review the disclaimer below.
