MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD CHILDRENS- dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci 
CVS Pharmacy

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DRUG FACTS

Active ingredients for Nighttime (in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Active ingredients for Daytime (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose for Nighttime

Pain reliever / fever reducer

Antihistamine / Cough suppressant

Nasal Decongestant

Purpose for Daytime

Cough suppressant

Expectorant

Nasal decongestant

Uses

Nighttime

Daytime

Warnings

NIGHTTIME

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

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

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

Nighttime

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 
  • in a child who is taking 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
  • with any other drug containing diphenhydramine, even one used on skin.
  • If your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • to make a child sleepy

Daytime

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. 

Ask a doctor before use if you have

Nighttime

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

Daytime

  • 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 you are

Nighttime

  • taking the blood thinning drug warfain
  • taking sedative or tranquilizers

When using these products

Nighttime

  • do not use more than directed
  • marked drowsiness may occur
  • excitablity may occur, especially in children
  • sedatives and tranquilizer may increase drowsiness

Daytime

  • do not use more than directed

Stop use and ask a doctor if

Nighttime

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

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Nighttime

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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

Daytime

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

Directions

Nighttime

Daytime

Age Dose 
 children 6 years to under 12 years 10 mL every 4 hours
 children 4 years to under 6 years 5 mL every 4 hours
 children under 4 years do not use

Other information

Nighttime

Daytime

Inactive ingredients

Nighttime

citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Daytime

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum

Questions or comments?

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

Principal Display Panel

Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**

Children's

multi-symptom

Nighttime Cold

ACETAMINOPHEN 325 mg (pain reliever / fever reducer)

DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)

PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)

 Relieves:

Nasal and chest congestion

Reduces fever

Soothes cough and sore throat

Berry Flavor Liquid

Dosage Cup Included

Ages 6 - 11 Years

FL OZ (mL)

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold

DAYTIME

Compare to active ingredients in Children's Mucinex® Multi-Symptom Cold*

Children's

multi-symptom cold

DEXTROMETHORPHAN HBr 5 mg (Cough Suppressant)

GUAIFENESIN 100 mg (expectorant)

PHENYLEPHRINE HCI 2.5 mg (Nasal Decongestant)

Relieves:

Nasal and chest congestion

Soothes cough

Thins and loosens mucus

Berry Flavor Liquid

Dosage cup included

Ages 4 to 11 years

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

1-800-SHOP CVS

Product Label

Acetaminophen 325 mg, Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg Dextromethorphan HBr 5 mg, Guaifenesin 100 mg, Phenylephrine HCI 2.5 mg

CVS HEALTH Children's Multi-Symptom Nighttime Cold Children's Multi-Symptom Cold

MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD  CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-820
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-820-081 in 1 KIT; Type 0: Not a Combination Product02/28/201702/28/2025
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 118 mL
Part 1 of 2
MULTI SYMPTOM COLD DAYTIME  CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
Product Information
Item Code (Source)NDC:69842-607
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 CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-607-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/28/201702/28/2025
Part 2 of 2
MULTI SYMPTOM NIGHTTIME COLD  CHILDRENS
acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Product Information
Item Code (Source)NDC:69842-606
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 CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-606-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/28/201702/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/28/201702/28/2025
Labeler - CVS Pharmacy (062312574)

Revised: 3/2024
Document Id: da039e19-082f-4775-ab8a-b8d7cf5441a2
Set id: ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e
Version: 4
Effective Time: 20240306
 
CVS Pharmacy