CHILDRENS PEDIACLEAR COUGH- diphenhydramine hydrochloride liquid

Childrens PediaClear Cough by

Drug Labeling and Warnings

Childrens PediaClear Cough by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CHILDREN’S PEDIACLEAR COUGH

NDC: 58809-750-50

Drug Facts

Active ingredients (in each 1 mL)

Diphenhydramine HCl 6.25 mg

Purpose

Cough Suppressant

Uses

• temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

may cause excitability, especially in children

Do not use

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

Ask a doctor before use if your child has

• glaucoma
  
• a breathing problem such as emphysema or chronic bronchitis
  
• a cough that lasts or is chronic such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus)
  
• Ask a doctor before use if the child is taking sedatives or tranquilizers

When using this product

• do not use more than directed
  
• may cause marked drowsiness
  
• sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if:

• symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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

• take every 4 hours, or as directed by a doctor
  
• do not take more than 6 doses in 24 hours or as directed by a doctor
  
• do not give more than directed or exceed the recommended daily dosage
  
• use only with enclosed dropper
  
• do not use enclosed dropper for any other drug product
  
• Children 6 to under 12 years of age: 2 mL (2 dropperfuls)
  
• Children under 6 years of age: ask a doctor

Other Information

• store at controlled room temperature 15°-30°C (59°-86°F)
  
• Tamper Evident: Do not use if seal under cap is broken or missing.

Inactive ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

Call 1-888-535-0305 9 a. m. - 5 p. m. CST

Professional Labeling

Use Only as Directed by a Doctor.

• Children 2 to under 6: 1 mL (1 dropperful) years of age
  
• Children under 2 years of age: Not Recommended
  
• Take every 4 hours.
  
• Do not exceed 6 doses in 24 hours.

PRINCIPAL DISPLAY PANEL

NDC: 58809-750-50
Children’s
PediaClear
Cough
Liquid drops
1.69 fl. oz. (50 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS PEDIACLEAR COUGH 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-750
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 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-750-50	50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/25/2019

Labeler - GM Pharmaceuticals, INC (793000860)