CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid

Childrens Nighttime Cold and Cough by

Drug Labeling and Warnings

Childrens Nighttime Cold and Cough by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

PURPOSE

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

INDICATIONS & USAGE

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

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 DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

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

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

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

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.

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INGREDIENTS AND APPEARANCE

CHILDRENS NIGHTTIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-315
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-315-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-315)