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

Description

Drug Facts

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
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
Warnings

Do not exceed recommended dosage.

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].

Questions Comments?

Call 1-800-543-9560

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.

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

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
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
Warnings

Do not exceed recommended dosage.

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].

Questions Comments?

Call 1-800-543-9560

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.

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