MULTI SYMPTOM NIGHTTIME COLD- acetaminophen diphenhydramine hci phenylephrine hci liquid 
CVS Pharmacy

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.

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DRUG FACTS

Active ingredients (in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Purpose

Pain reliever / fever reducer

Antihistamine / Cough suppressant

Nasal Decongestant

Uses

Warnings

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

  • 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


Ask a doctor before use if you have

  • 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)


Ask a doctor or pharmacist before use if you are

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

When using these products

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

Stop use and ask a doctor if

  • 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.


.

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

Directions

Other information


Inactive ingredients

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


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 congestion

Reduces fever

Soothes cough and sore throat

Ages 6 to 11 Years

Berry Flavor Liquid

Dosage Cup Included

FL OZ (mL)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

Product Label

Acetaminophen 325 mg, Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg

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

MULTI SYMPTOM NIGHTTIME COLD 
acetaminophen diphenhydramine hci phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-506
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)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Mixed) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-506-041 in 1 BOX04/30/201804/30/2025
1118 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 finalpart34104/30/201804/30/2025
Labeler - CVS Pharmacy (062312574)

Revised: 11/2022
Document Id: 9f35dd1a-cc20-4aed-824f-8604692d4643
Set id: 991019f8-b4c2-45b8-ad71-fe099e6d99a7
Version: 3
Effective Time: 20221121
 
CVS Pharmacy