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

NightTime Cold and Cough by

Drug Labeling and Warnings

NightTime Cold and Cough by is a Otc medication manufactured, distributed, or labeled by ASSURED / DOLLAR TREE (Greenbrier International, Inc.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCI 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Uses

• temporarily relieves
  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritations as may occur with a cold

Warnings

Do not use

• in a child under 4 years of age
• in a child who is 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 child's prescription drug contains an MAOI,  ask a doctor or pharmacist before giving this product.
• with any other product containing diphenhydramine, even one used on skin
• for the purpose of making your child sleepy

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough that occurs with too much phlegm (mucus)
• chronic cough that lasts, or as occurs with asthma
• a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers 

When using this product,

• do not exceed recommended dosage
• marked drowsiness may occur
• excitability may occur, especially in children
• sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a fever
• cough persists for 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 (1-800-222-1222) right away.

Directions

• Do not give more than 6 doses in 24 hours unless directed by a doctor.
• measure only with dosing cup provided Do not use any other dosing device
• keep dosing cup with product
• mL=mililiter
• shake well before using

• Age: Dose
• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: do not use unless directed by a doctor
• children under 4 years: do not use

Other Information

• each 5 mL contains: sodium 3 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.
• protect from light

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

COMPARE TO ACTIVE INGREDIENTS IN CHILDREN'S TRIAMINIC® NIGHT TIME COLD & COUGH*

CHILDREN'S

Triacting Night Time Cold & Cough

Diphenhydramine HCl 6.25 mg

Antihistamine / Cough Suppressant

Phenylephrine HCl 2.5 mg

Nasal Decongestant

Relieves Itchy Throat, Cough, Runny Nose & Stuffy Nose

AGES 6-11

ALCOHOL-FREE

Grape flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare distributor of Children's Triaminic® Night Time Cold and Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

Package Label

ASSSURED Children's Triacting Nighttime Cold & Cough

 

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND COUGH  CHILDREN
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0379
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 HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0379-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/31/2017

Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)