CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION- diphenhydramine hcl, phenylephrine hcl liquid

CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION by

Drug Labeling and Warnings

CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 10 ML)

Diphenhydramine HCl, USP 12.5 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Antihistamine/Cough suppressant

Nasal decongestant

USES

• temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS

Do not use

• to sedate a child or 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.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DIRECTIONS

• do not take more than 6 doses in any 24-hour period
• do not exceed recommended dosage
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

age	dose
adults and children 12 years and over	20 ml every 4 hours
children 6 to under 12 years	10 ml every 4 hours
children under 6 years	do not use

OTHER INFORMATION

• each 10 ml contains: sodium 8 mg
• store at 20 -25°C (68 -77°F)

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's
Dimetapp®
Nighttime
Cold &
Congestion

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves Nasal Symptoms

• ☑ Stuffy Nose
• ☑ Runny Nose
• ☑ Sneezing

Plus Other Symptoms

• ☑ Itchy, Watery Eyes
• ☑ Cough

Packaged with Tamper-Evident
bottle cap. Do Not Use if breakable
ring is separated or missing.

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's
Dimetapp®

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Nighttime
Cold &
Congestion

Relieves Nasal Symptoms

• ☑ Stuffy Nose
• ☑ Runny Nose
• ☑ Sneezing

Plus Other Symptoms

• ☑ Itchy, Watery Eyes
• ☑ Cough

For Ages
6 Yrs.
& Over

4 FL OZ (118 ml) grape flavor

INGREDIENTS AND APPEARANCE

CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION 
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2247
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE (clear, purple liquid)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2247-13	1 in 1 CARTON	11/01/2007
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/01/2007

Labeler - Wyeth Consumer Healthcare LLC (828831730)