Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 61980e57-5b94-4ae2-8e08-848749e4abcd

Route

ORAL

Published

Effective Date 2023-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg) Diphenhydramine (6.25 mg)

Inactive Ingredients

Acesulfame Potassium Sodium Benzoate Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Propylene Glycol Water Trisodium Citrate Dihydrate Fd&c Blue No. 1 Maltitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-11-30

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine/Cough suppressant Nasal decongestant

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Uses

temporarily relieves:
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

Do not give more than 6 doses in 24 hours unless directed by a doctor.
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter
shake well before using

age	dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years of age	do not use

Do Not Use

in a child under 4 years of age
in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Package Label

READYinCASE Children's Triacting Night Time Cold and Cough

Other Information

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F). Do not refrigerate
protect from light

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough

children's triacting nighttime

Cold & Cough

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

antihistamine/

cough suppressant

nasal decongestant

relieves:

cough
runny, stuffy nose
itchy throat

for ages 6 to 11

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product,

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

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.

Active Ingredients (in Each 5 Ml)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as chronic bronchitis
chronic cough that lasts, or as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves:
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

Do not give more than 6 doses in 24 hours unless directed by a doctor.
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter
shake well before using

age	dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years of age	do not use

Do Not Use (Do not use)

in a child under 4 years of age
in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Package Label

READYinCASE Children's Triacting Night Time Cold and Cough

Other Information (Other information)

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F). Do not refrigerate
protect from light

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough

children's triacting nighttime

Cold & Cough

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

antihistamine/

cough suppressant

nasal decongestant

relieves:

cough
runny, stuffy nose
itchy throat

for ages 6 to 11

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product, (When using this product,)

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as chronic bronchitis
chronic cough that lasts, or as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold", "Purposes": "Antihistamine/Cough suppressant Nasal decongestant ", "Directions": "Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter shake well before using age dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use", "Do not use": "in a child under 4 years of age in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy", "Package Label": "READYinCASE Children's Triacting Night Time Cold and Cough", "Other information": "each 5 mL contains : sodium 3 mg store between 20-25°C (68-77°F). Do not refrigerate protect from light", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough children's triacting nighttime Cold & Cough Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg antihistamine/ cough suppressant nasal decongestant relieves: cough runny, stuffy nose itchy throat for ages 6 to 11 Grape Flavor FL OZ (mL) *This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING. Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262", "When using this product,": "do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.", "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.", "Active ingredients (in each 5 mL)": "Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg", "Ask a doctor before use if the child has": "heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis chronic cough that lasts, or as occurs with asthma cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if the child is": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:23.692621 · Updated: 2026-03-14T23:01:24.251815