DrKids Childrens Multi Symptom Cold Cough and Congestion DM

Manufacturer
Calmco
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:11:24

Label at a glance#

ProductDrKids Childrens Multi Symptom Cold Cough and Congestion DM
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Indications and uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help your child get to sleep ■ nasal congestion due to a cold ■ stuffy nose

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ do not give more than 6 times in 24 hours ■ give the recommended number of vials below following the instructions under “Easy to Use” on the side panel. ■ empty all liquid in each Single-Use Vial when dosing ■ use the chart below to confirm the dose Dosing chart Age (years) Dose (mL) under 4 years Do not use 4 to 5 years 1 Single-Use V...

Label contents#

Full prescribing information#

Active Ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 5mg

Guaifenesin, 100mg

Phenylephrine HCl, 2.5mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help your child get to sleep ■ nasal congestion due to a cold ■ stuffy nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor if your child has

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other decongestant or stimulant.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not get better within 7 days or occur with fever ■ cough lasts more than 7 days, 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

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

■ do not give more than 6 times in 24 hours

■ give the recommended number of vials below following the instructions under “Easy to Use” on the side panel.

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

■ use the chart below to confirm the dose

Dosing chart

Age (years)Dose (mL)
under 4 yearsDo not use
4 to 5 years1 Single-Use Vial (5mL) every 4 hours. Do not give more than 6 times in 24 hours
6 to 11 years2 Single-Use Vials (10mL) every 4 hours. Do not give more than 6 times in 24 hours

Other information

OTHER SAFETY INFORMATION

■ each Single -Use vial contains 5mg of sodium

■ store at 20-25°C (68-77°F)

■ 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, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

941-202-3270 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
73282-011673282-0116-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
1934d927-975b-7ab1-e063-6294a90a3775d4ebf09c-c364-2529-e053-2995a90ae53f2024-05-24WarningsExact identifier
spl set id: d4ebf09c-c364-2529-e053-2995a90ae53f

Reported adverse events (FAERS/openFDA)#

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