ALLERGY PLUS CONGESTION- diphenhydramine hcl, phenylephrine hcl tablet, film coated

Allergy Plus Congestion by

Drug Labeling and Warnings

Allergy Plus Congestion by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
  • sinus congestion and pressure
• temporarily relieves these symptoms due to the common cold:
  • nasal congestion
  • runny nose
  • sneezing
  • sinus congestion and pressure

Warnings

Do not use

• 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
• diabetes
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• thyroid disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

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

Stop use and ask a doctor if

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

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 (1-800-222-1222) right away.

Directions

• adults and children 12 years of age and over
  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
• children under 12 years: do not use this product in children under 12 years of age

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare®

NDC: 36800-985-08

REGULAR STRENGTH

Allergy Plus
Sinus

DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl

ANTIHISTAMINE NASAL DECONGESTANT

Relief of:

Sneezing   Itchy, Watery Eyes
Runny Nose  Itchy Throat
Sinus Congestion   Sinus Pressure
Easy to Swallow

QUALITY GUARANTEED 

COMPARE TO BENADRYL-D® ALLERGY PLUS SINUS active ingredients*

actual size

24 TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl-D® Allergy Plus Sinus.

50844   ORG051248508

TopCare 44-485

INGREDIENTS AND APPEARANCE

ALLERGY PLUS CONGESTION 
diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-985
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;485
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-985-08	2 in 1 CARTON	08/10/2005	03/19/2022
1		12 in 1 BLISTER PACK; 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	08/10/2005	03/19/2022

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(36800-985)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(36800-985)