pentrexcilina night time

pentrexcilina night time
SPL v1
SPL
SPL Set ID 26fb4060-70bd-d5b9-e063-6294a90ad2bd
Route
oral
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
magnesium stearate anhydrous dibasic calcium phosphate d&c red no. 27 microcrystalline cellulose polyvinyl alcohol, unspecified talc titanium dioxide lecithin, soybean silicon dioxide croscarmellose sodium

Identifiers & Packaging

Pill Appearance
Imprint: D;25 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-11-15

Purpose

Antihistamine

Description

Drug Facts


Medication Information

Active Ingredient

Diphenhydramine HCl 25mg

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the
  • common cold
Purpose

Antihistamine

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 of age: 1 caplet

Children under 6 years of age: do not use

Other Information
  • Each caplet 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 is broken or missing.

Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, D & C Red #27, Dicalcium Phosphate, Lecithin, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc.

Description

Drug Facts

Principal Display Panel

Daytime Xtreme Allergy Relief

Cetirizine HCl 10mg

Non-Drowsy

NDC 69729-137-14

14 Tablets

DUO PACK

PENTREXCILINA

ALL DAY & ALL NIGHT

24 HOUR ALLERGY RELIEF OF:

Sneezing/ Estornudos

Runny nose/ Escurrimiento nasal

Itchy, watery eyes/ Irritación y ojos llorosos

Itchy throat/ Picazón en garganta

Nighttime Severe Allergy Relief

Sleep-aid

Diphenhydramine HCl 25mg

NDC 69729-106-14

14 Caplets

Made for RRX

Exclusively distributed by:

OPMX

Chula Vista CA 91910

Phone: 619-600-5632

Do Not Use
  • with any other product containing dyphenhydramine, even one used on skin
  • to make a child sleepy
Drug Facts

Drug Facts

Overdose Warning

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 children even if you do not notice any signs or symptoms.

Questions Or Comments?

Call (619) 600-5632

Monday through Friday 9AM- 5PM EST

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 professional before use

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
Ask Your Doctor Or Pharmacist Before Use If You Are
  • taking sedative or tranquilizers

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25mg

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the
  • common cold
Purpose

Antihistamine

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 of age: 1 caplet

Children under 6 years of age: do not use

Other Information (Other information)
  • Each caplet 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 is broken or missing.

Inactive Ingredients (Inactive ingredients)

Colloidal silicon Dioxide, Croscarmellose Sodium, D & C Red #27, Dicalcium Phosphate, Lecithin, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc.

Principal Display Panel (Principal display Panel)

Daytime Xtreme Allergy Relief

Cetirizine HCl 10mg

Non-Drowsy

NDC 69729-137-14

14 Tablets

DUO PACK

PENTREXCILINA

ALL DAY & ALL NIGHT

24 HOUR ALLERGY RELIEF OF:

Sneezing/ Estornudos

Runny nose/ Escurrimiento nasal

Itchy, watery eyes/ Irritación y ojos llorosos

Itchy throat/ Picazón en garganta

Nighttime Severe Allergy Relief

Sleep-aid

Diphenhydramine HCl 25mg

NDC 69729-106-14

14 Caplets

Made for RRX

Exclusively distributed by:

OPMX

Chula Vista CA 91910

Phone: 619-600-5632

Do Not Use (Do not use)
  • with any other product containing dyphenhydramine, even one used on skin
  • to make a child sleepy
Drug Facts

Drug Facts

Overdose Warning (OVERDOSE WARNING)

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 children even if you do not notice any signs or symptoms.

Questions Or Comments? (Questions or comments?)

Call (619) 600-5632

Monday through Friday 9AM- 5PM EST

When Using This Product (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, (If pregnant or breast-feeding,)

ask a professional before use

Ask A Doctor Before Use If You Have (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
Ask Your Doctor Or Pharmacist Before Use If You Are (ask your doctor or pharmacist before use if you are)
  • taking sedative or tranquilizers

Advanced Ingredient Data


Raw Label Data

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