Active Ingredients For Nighttime (In Each 10 Ml)
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Daytime Cold And Cough And Nighttime Cold And Congestion Kit
FDA Label NDC 0363-4590
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Daytime Cold And Cough And Nighttime Cold And Congestion (NDC 0363-4590). 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 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
- nasal congestion
- cough
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis)
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- 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,psychiatic 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
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitablity may occur, especially in children
- do not use more than directed
- marked drowsiness may occur
- 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
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with a 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 (1-800-222-1222) right away.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Nighttime
- do not take more than 6 doses in any 24 hours period
- do not exceed recommended dosage
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = mililiter
- do not take more than 6 doses in any 24 hours period
- measure only with dosing cup provided. Do not use any other dosing dosing device.
- keep dosing cup with product
- mL = mililiter
| Age | Dose |
| adults and children 12 years and over | 20 mL every 4 hours |
| childen 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 20-25°C (68-77°F)
- do not refrigerate
- protect from light
- each 10 mL contains: 5 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Daytime
Inactive Ingredients
Nighttime
acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C Blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate
Daytime
citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Dimetapp® Cold & Cough & Nighttime Cold & Congestion††
Children's Cold & Congestion Relief
DIPHENHYDRAMINE HCl 12.5 mg /
ANRIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCl 5 mg /
NASAL DECONGESTANT
Nighttime
Alcohol Free
- Relieves stuffy nose, runny nose, sneezing, itchy & watery eyes & coughing
- Relieves nasal congestion, runny nose, itchy & watery eyes, sneezing & coughing
AGES 6 YEARS & OLDER
Grape flavor
DOSING CUP INCLUDED
AGES 6 + YEARS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
††This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Nighttime Cold & Congestion.
DAYTIME
Children's Cold & Cough Relief
BROMPHENIRAMINE MALEATE 2 mg
ANTIHISTAMINE
DEXTROMETHORPHAN HBr 10 mg /
COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg /
NASAL DECONGESTANT
Daytime
Alcohol Free
AGES 6 YEARS & OLDER
Grape flavor
FL OZ (mL)
††This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Children's Dimetapp® Cold & Cough.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Product Label
WALGREENS Children's Cold & Congestion Relief, Children's Cold & Cough Relief
* Please review the disclaimer below.
