CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid 
AptaPharma Inc.

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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Children's Nighttime Cold & Cough

Drug Facts

Active ingredients (in each 5 mL)
Diphenhydramine HCI, USP              6.25 mg
Phenylephrine HCI, USP                    2.5 mg

Purpose
Diphenhydramine HCI, USP                 Antihistamine/Cough suppressant
Phenylephrine HCI, USP                      Nasal decongestant

Uses
• temporarily controls cough due to minor throat and bronchial
   irritation and relieves nasal congestion as may occur with a cold
• temporarily relieves the following symptoms due to hay fever or
   other upper respiratory allergies:
          • sneezing                  • runny nose
          • itchy, watery eyes     • itchy nose or throat

Warnings
Do not use
• with any other product containing diphenhydramine, even
  one used on the skin
• 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.

Ask a doctor before use if the child has
• heart disease          • high blood pressure         •thyroid disease
• diabetes                 • glaucoma
• abreathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is
• taking sedatives or tranquilizers.

When using this product
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if
• nervousness, dizziness or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough lasts more than 7 days, comes back, or occurs
with fever, rash, or persistent headache.
These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
do not use more than directed
do not take more than 6 doses in any 24-hour period
mL=milliliter

Age                                                          Dose
 Children 6 to under 12 years of age 10 mL every 4 hours
 Children 4 to under 6 years of age Do not use unless directed by a doctor
 Children under 4 years of age Do not use

Other information
• each 10 mL contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided

Inactive ingredients
anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

CVS
HealthTM

Compare to the active
ingredients in Triaminic®
Night Time Cold & Cough*

Children's
Nighttime
Cold & Cough

Free of alcohol, dyes &
artificial sweeteners

DIPHENHYDRAMINE HCl
Antihistamine;
Cough suppressant

PHENYLEPHRINE Hel
Nasal decongestant

Relieves:
Cough, stuffy nose
& itchy throat

Grape Flavor

For Ages
6 to 12 Years

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by Novartis
Consumer Health, Inc., distributor of Triaminic® Night Time
Cold & Cough.

Lot:
Exp:

LR-115           #194556

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34874

√CVS Quality
Money Back Guarantee

↓Product Package↓

315-26 Label

                                  Children's Nighttime Cold & Cough by CVS Pharmacy, Inc.

res

CHILDRENS NIGHTTIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-315-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/201812/01/2022
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-315)

Revised: 12/2022
 
AptaPharma Inc.