rynex pe

rynex pe
SPL v9
SPL
SPL Set ID 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef
Route
oral
Published
Effective Date 2020-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
brompheniramine (1 mg) phenylephrine (2.5 mg)
Inactive Ingredients
citric acid monohydrate fd&c red no. 40 methylparaben potassium citrate potassium sorbate propylparaben propylene glycol water sorbitol sucralose

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2011-03-07
Description

Drug Facts

Medication Information

Warnings

Do not exceed recommended dosage.

Uses

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

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

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:

Consult a doctor
Other Information

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive Ingredients

Bubblegum Flavor, Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50569-3

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

Section 53414-9

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

Section 55105-1
Active Ingredients

  (in each 5 nil teaspoonful) 		Purpose
Brompheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 2.5 mg Nasal Decongestant
Questions Comments?

Call 1-800-543-9560

When Using This Product
  • excitability may occur, especially in children
  • may cause drowsiness
  • sedalives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Do Not Take This Product
  • if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (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.
Stop Use and Ask Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
  • new symptoms occur
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
Principal Display Panel 473 Ml Bottle Label

Rynex PE

E

NDC 0485-0202-16

Rynex PE



Antihistamine • Nasal Decongestant

Sugar Free • Alcohol Free



• Gluten Free

Each teaspoonful (5 mL)



for oral administration contains:



Brompheniramine Maleate 1 mg



Phenylephrine HCl 2.5 mg

Bubblegum Flavor



FOR PROFESSIONAL USE ONLY

Tamper evident by foil seal under cap.



Do not use if foil seal is broken or



missing.

Manufactured for:



EDWARDS



Pharmaceuticals, Inc.



Ripley, MS 38663

16oz. (473 mL)

Structured Label Content

Warnings

Do not exceed recommended dosage.

Uses

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

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

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 6 years of age:

Consult a doctor
Other Information (Other information)

Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

Bubblegum Flavor, Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredients

  (in each 5 nil teaspoonful) 		Purpose
Brompheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 2.5 mg Nasal Decongestant
Questions Comments?

Call 1-800-543-9560

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • may cause drowsiness
  • sedalives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Do Not Take This Product (Do not take this product)
  • if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (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.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
  • new symptoms occur
Ask A Doctor Before Use If You Have (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
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

Rynex PE

E

NDC 0485-0202-16

Rynex PE



Antihistamine • Nasal Decongestant

Sugar Free • Alcohol Free



• Gluten Free

Each teaspoonful (5 mL)



for oral administration contains:



Brompheniramine Maleate 1 mg



Phenylephrine HCl 2.5 mg

Bubblegum Flavor



FOR PROFESSIONAL USE ONLY

Tamper evident by foil seal under cap.



Do not use if foil seal is broken or



missing.

Manufactured for:



EDWARDS



Pharmaceuticals, Inc.



Ripley, MS 38663

16oz. (473 mL)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.226842 · Updated: 2026-03-14T23:14:06.332069