Active Ingredients (In Each 10 Ml)
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Cold And Congestion Liquid
FDA Label NDC 0363-0058
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 Cold And Congestion (NDC 0363-0058). 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 (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antihistamine/Cough suppressant
Nasal decongestant
Uses
- 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
Do Not Use
- 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.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlem (mucus)
- a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When Using This Product
- 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
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- 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 a fever, rash, or persistent headache.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour 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 = milliliter
| age | dose |
| adults and children 12 years and over | 20 mL every 4 hours |
| children 6 to 11 years | 10 mL every 4 hours |
| children under 6 years | do not use |
Other Information
- each 10 mL contains: sodium 6mg
- store at 20-25°C (68-77°F)
- Do not refrigerate
- protect from light
Inactive Ingredients
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
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
children's
COLD & CONGESTION
DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††
- Nighttime
- Alcohol Free
- 6 years & older
FL OZ (mL)
GRAPE FLAVOR
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY : WALGREEN CO
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Package Label
WALGREENS Children's Cold & Congestion Grape Flavor
* Please review the disclaimer below.
