DrKids Childrens Muti Symptom Cold Flu and Sore Throat Nighttime

Manufacturer
Calmco LLC
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:11:51

Label at a glance#

ProductDrKids Childrens Muti Symptom Cold Flu and Sore Throat Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure8 sections

Indications and uses

■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sneezing ■ cough ■ controls cough to help your child get to sleep ■ temporarily reduces fever

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see Overdose warning) ■ dose as follow or as directed by a doctor. ■ follow the instructions under "Easy to Use" on the side panel ■ empty all liquid in each Single-Use Vial when dosing ■ children 6 - 11 years of age: 1 single-use vial (10mL) every 4 hours while symptoms last; do not give more than 5 dos...

Label contents#

Full prescribing information#

Active Ingredients (in each 10mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, 325mg

Diphenhydramine HCl, 12.5mg

Phenylephrine HCl, 5mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sneezing ■ cough

■ controls cough to help your child get to sleep

■ temporarily reduces fever

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

■ more than 5 doses in 24 hours, which is the maximum daily amount for this product

■ with other drugs containing acetaminophen.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ to make a child sleepy ■ with any other product containing diphenhydramine, even one used on the skin■ if 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin ■ taking any other nasal decongestant or stimulant ■ taking any other pain reliever/ fever reducer ■ taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ do not exceed recommended dosage (see overdose warning)

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose Warning

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms

Directions

DOSAGE & ADMINISTRATION SECTION

■ this product does not contain directions or complete warnings for adult use

■ do not give more than directed (see Overdose warning)

■ dose as follow or as directed by a doctor.

■ follow the instructions under "Easy to Use" on the side panel

■ empty all liquid in each Single-Use Vial when dosing

■ children 6 - 11 years of age: 1 single-use vial (10mL) every 4 hours while symptoms last; do not give more than 5 doses in any 24 hour period

■ children under 6 years of age: do not use

Dosing Chart

Age (Years) Dose (mL)
6 - 11 years1 Single-use vial (10mL) every 4 hours. Do not give more than 5 times in 24 hours.

Other Information

OTHER SAFETY INFORMATION

■ each Single -Use vial contains 11mg of sodium

■ store at 20-25°C (68-77°F)

■ do not refrigerate

■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 941-202-3207 or visit www.DrKids.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-011473282-0114-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1934dc31-88cd-8784-e063-6394a90a89d2d4c694a6-5d38-1613-e053-2a95a90a87172024-05-24WarningsExact identifier
spl set id: d4c694a6-5d38-1613-e053-2a95a90a8717

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.