ED A-HIST- chlorpheniramine maleate and phenylephrine hydrochloride tablet

ED A-HIST by

Drug Labeling and Warnings

ED A-HIST by is a Otc medication manufactured, distributed, or labeled by Syntho Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each tablet)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

• Do not exceed recommended dosage.

Do not use this product

• 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 a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus
• difficulty in urination due to enlargement of the prostate gland

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

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by a fever
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
• Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor
• Children under 6 years of age: Consult a doctor.

Inactive ingredients

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, HPMC, Propylene Glycol, Tricetin, Titanium Dioxide, Caramel Color, Riboflavin, Yellow  Oxide, Lake Blend Black

Questions or Comments?

Call 1-800-664-1490 Rev. 9/22

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 66576 -254-01

ED A-HIST TABLETS

Antihistamine Nasal Decongestant

Each tablet contains: Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Berwyn,PA 19312

100 tablets

INGREDIENTS AND APPEARANCE

ED A-HIST 
chlorpheniramine maleate and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66576-254
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRICETIN (UNII: 5627PY99ZO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARAMEL (UNII: T9D99G2B1R)
RIBOFLAVIN (UNII: TLM2976OFR)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	brown	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	E;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66576-254-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/02/2022

Labeler - Syntho Pharmaceuticals, Inc. (088797407)

Registrant - Syntho Pharmaceuticals, Inc. (088797407)

Establishment
Name	Address	ID/FEI	Business Operations
Syntho Pharmaceuticals, Inc.		088797407	manufacture(66576-254)