PENTREXCILINA SEVERE ALLERGY- diphenhydramine hydrochloride tablet, film coated

Pentrexcilina Severe Allergy by

Drug Labeling and Warnings

Pentrexcilina Severe Allergy by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Diphenhydramine HCl 25 mg

Purpose

• Active ingredient (in each tablet): Purpose
• Diphenhydramine HCl 25mg: 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
• temporarily relieves these symptoms due to the common cold.

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

• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• 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
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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. Prompt medical attention is critical for adults as well as for children even if you not notice ant signs or symptoms.

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 1 or 2 caplets
• children 6 to under 12 years: 1 caplet
• children under 6 years: do not use

Other information

• each tablet contains:calcium 23.52 mg
• store at controlled room temperature 20-25°C (68-77°F).
• read all product information before using
• Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Colloidal silicon dioxide, Croscarmellose Sodium, D&C red no. 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, talc

Questions or comments?

call (619) 600-5632

Monday through Friday 9AM - 5PM EST

PRINCIPAL DISPLAY PANEL

NDC: 69729-106-30

Diphenhydramine HCL 25mg/Antihistamine

Pentrexcilina®

SEVERE ALLERGY

Itchy, Watery Eyes - Picazón y lagrimeo en los ojos

Sneezing - Estornudo

Itchy Throat - Picazón en la garganta

Runny Nose - Escurrimiento Nasal

30 CAPLETS

INGREDIENTS AND APPEARANCE

PENTREXCILINA SEVERE ALLERGY 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-106
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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	D;25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-106-30	1 in 1 CARTON	05/17/2024
1		30 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 Drug	M012	05/17/2024

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(69729-106)