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#
Contacts and useful links#
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
| 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
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↓
Children's Nighttime Cold & Cough by CVS Pharmacy, Inc.
res
Products#
Every source-derived product name is available through these pages.
- Childrens Nighttime Cold and Cough
- DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- WATER
- SODIUM BENZOATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-315 | 76281-315-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 13e66b7a-6a39-48c9-ba8f-2c2dee618307 | 0163af5d-5256-404e-9195-624c4ffc8087 | 2022-12-16 | Warnings | 0163af5d-5256-404e-9195-624c4ffc8087 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
