DRKIDS CHILDRENS MUTI SYMPTOM COLD FLU AND SORE THROAT NIGHTTIME- acetaminophen 325mg, diphenhydraine hcl 12.5mg, phenylephrine hcl 5mg solution 
Calmco LLC

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DrKids Children's Multi-Symptom Cold, Flu & Sore Throat Night-time

Active Ingredients (in each 10mL)

Acetaminophen, 325mg

Diphenhydramine HCl, 12.5mg

Phenylephrine HCl, 5mg

Purposes

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

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

Warnings

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

■ 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

■ 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

■ 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

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

■ 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

Overdose Warning

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

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

■ 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

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?

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

Package Label

Package

DRKIDS CHILDRENS MUTI SYMPTOM COLD FLU AND SORE THROAT NIGHTTIME 
acetaminophen 325mg, diphenhydraine hcl 12.5mg, phenylephrine hcl 5mg solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
MALTITOL (UNII: D65DG142WK)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0114-616 in 1 CARTON02/06/2024
110 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/06/202402/06/2024
Labeler - Calmco LLC (079308308)

Revised: 5/2024
 
Calmco LLC