Childrens Nighttime Cold and Cough

Manufacturer
AptaPharma Inc.
Effective date
2018-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:45:41

Label at a glance#

ProductChildrens Nighttime Cold and Cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - ASK DOCTOR SECTION

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)

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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 Label315-26 Label

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-31576281-315-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
13e66b7a-6a39-48c9-ba8f-2c2dee6183070163af5d-5256-404e-9195-624c4ffc80872022-12-16WarningsExact identifier
spl set id: 0163af5d-5256-404e-9195-624c4ffc8087

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.