COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, triprolidine hcl solution 
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

----------

CVS 44-063

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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.
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS
Health®

Compare to the active
ingredients in Mucinex®
Nightshift® Cold & Flu*

Nighttime
Cold & Flu
ACETAMINOPHEN
 - Pain reliever/Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
TRIPROLIDINE HCl - Antihistamine

MULTI-SYMPTOM

Controls cough
Relieves fever & sore throat
Relieves runny nose & sneezing

FOR AGES 12+

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

*This product is not manufactured or
distributed by RB Health (US) LLC, owner
of the registered trademark Mucinex®
Nightshift® Cold & Flu.

B-063-45 REV0423A
50844    REV0423A06345

Distributed by: CVS Pharmacy, Inc., One CVS Drive
Woonsocket, RI 02895 © 2023 CVS/pharmacy V-19849

CVS 44-063

CVS 44-063

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, triprolidine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-963
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-963-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/23/2023
Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(51316-963) , pack(51316-963)

Revised: 10/2023
Document Id: 2323a56a-8ec7-403a-ac0b-dfdddc3edfcb
Set id: 0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba
Version: 2
Effective Time: 20231023
 
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED