COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, triprolidine hcl solution

Cold and Flu by

Drug Labeling and Warnings

Cold and Flu by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• temporarily relieves these common cold and flu symptoms:
  • headache
  • minor aches and pains
  • sneezing
  • runny nose
  • itching of the nose or throat
  • cough
  • sore throat
  • itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep

Warnings

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

• 3 or more alcoholic drinks every day while using this product
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen

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

• rash
• blisters
• skin reddening

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

• do not take more than directed
• do not take more than 4 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years: do not use

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

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

INGREDIENTS AND APPEARANCE

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, triprolidine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-963
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-963-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/23/2023

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(51316-963) , pack(51316-963)