MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK- acetaminophen, diphenylhydramine hydrochloride, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Mucinex® Children's Day Time Multi-Symptom Cold and Mucinex® Children's Night Time Multi-Symptom Cold Triple Pack

Drug Facts

Active ingredients (in each 10 mL)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

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
  • 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
  • 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 before use if the child has

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • 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 the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

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 headache that lasts. 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

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum


1
may contain this ingredient

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses

Warnings

Do not use 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 before use if the child has

  • 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

When using this product do not use more than directed

Stop use and ask a doctor if

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

AgeDose
children 6 to under 12 years of age10 mL every 4 hours
children 4 to under 6 years of age5 mL every 4 hours
children under 4 years of agedo not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate2, xanthan gum


2
may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in Mexico

PRINCIPAL DISPLAY PANEL - Kit Carton

Pediatrician Recommended
TRIPLE
PACK

NDC 63824-944-34

READ ALL INFORMATION

Mucinex®
Children's

DAY TIME
MULTI-SYMPTOM
COLD

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant

Relieves Stuffy Nose
Controls Cough
Relieves Chest Congestion
Breaks up Mucus

Ages
4+ yrs

Very Berry
Flavor Liquid

THREE – 4 FL OZ (118mL)

NIGHT TIME
MULTI-SYMPTOM
COLD

Acetaminophen 325 mg–Pain Reliever/Fever Reducer
Diphenhydramine HCl 12.5–Antihistamine/
Cough Suppressant
Phenylephrine HCl mg–Nasal Decongestant

Relieves Stuffy Nose
Controls Cough
Relieves Runny Nose & Sneezing
Relieves Fever & Sore Throat

Ages
6+ yrs

Very Berry
Flavor Liquid

TOTAL – 12 FL OZ (354mL)

PRINCIPAL DISPLAY PANEL - Kit Carton
MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK 
acetaminophen, diphenylhydramine hydrochloride, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-944
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-944-341 in 1 CARTON05/25/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 236 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
MUCINEX CHILDRENS MULTI-SYMPTOM COLD 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride suspension
Product Information
Item Code (Source)NDC:63824-949
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
edetate disodium (UNII: 7FLD91C86K)  
FD&C red no. 40 (UNII: WZB9127XOA)  
propyl gallate (UNII: 8D4SNN7V92)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
trisodium citrate dihydrate (UNII: B22547B95K)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-949-011 in 1 CARTON
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/30/2018
Part 2 of 2
MUCINEX CHILDRENS  NIGHT TIME MULTI-SYMPTOM COLD
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-950
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
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
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
edetate disodium (UNII: 7FLD91C86K)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
propyl gallate (UNII: 8D4SNN7V92)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
trisodium citrate dihydrate (UNII: B22547B95K)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-950-211 in 1 CARTON
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/25/2022
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2022
Document Id: 37958be4-8974-4d55-986b-e525756a1a91
Set id: c7ab5201-8550-4bf4-957c-c8f049aeaa4a
Version: 2
Effective Time: 20220526
 
RB Health (US) LLC