GERI-DRYL- diphenhydramine hydrochloride liquid

GERI-DRYL by

Drug Labeling and Warnings

GERI-DRYL by is a Otc medication manufactured, distributed, or labeled by GERI-CARE PHARMACEUTICALS, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl, 12.5 mg.

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not use

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

Ask a doctor before use if you have

• a breathing problem or chronic cough that lasts, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• a sodium restricted diet
• trouble urinating due to enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machiney
• excitability may occur, especially in children.

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 to 6 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• do not exceed recommended dose
• adults and children 12 years and over: 10-20 mL (2 to 4 teaspoonsful)
• children under 12 years: consult a doctor

Other information

• each 5 mL teaspoonful contains: sodium 16 mg
• store at room temperature 15°C-30°C (59°F-86°F)
• do not freeze
• protect from light

Inactive ingredients

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERI-DRYL 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-780
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-780-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2016	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2016	07/31/2020

Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICALS, CORP (611196254)