COLD AND CONGESTION CHILDRENS NIGHTTIME- diphenhydramine hci, phenylephrine hcl liquid 
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 10 mL)

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Warnings

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

 age dose
adults and children 12 years and over20 mL every 4 hours
 children 6 to 11 years 10 mL every 4 hours
 children under 6 yearsdo not use

Other information

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††

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

Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg

WALGREENS Children's Cold & Congestion Grape Flavor

COLD AND CONGESTION  CHILDRENS NIGHTTIME
diphenhydramine hci, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MALTITOL (UNII: D65DG142WK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0058-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2016
Labeler - Walgreens (008965063)

Revised: 11/2020
Document Id: dcb12e86-fb64-4d01-b132-7f3dad038786
Set id: a7847413-e556-4f88-8a7f-a8528afbe927
Version: 5
Effective Time: 20201111
 
Walgreens