COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

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 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
  • sore throat
  • nasal congestion
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • headache
• temporarily reduces fever

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

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.
• 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 the user has

• difficulty in urination due to enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• heart disease
• diabetes
• thyroid disease
• liver disease
• high blood pressure

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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 exceed 4 doses per 24 hours
• mL = milliliter
• only use the dose cup provided

• adults and children 12 years and over: 30 mL every 4 hours
• children 6 to under 12 years: 15 mL every 4 hours
• children under 6 years: do not use

Other information

• each 15 mL contains: sodium 13 mg
• 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 yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

Questions or comments?

1-800-426-9391

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

• temporarily relieves common cold and flu symptoms:
  • headache
  • minor aches and pains
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
• temporarily reduces fever

Warnings

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

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

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.
• 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

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• excitability may occur, especially in children
• avoid alcoholic beverages
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

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
• redness or swelling is present
• new symptoms occur
• 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 exceed 4 doses per 24 hours
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 30 mL every 6 hours
• children under 12 years: do not use

Other information

• each 30 mL contains: sodium 13 mg
• 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, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

Principal display panel

COMBO PACK

• ♥CVS Health® Compare to the active ingredients in Vicks® DayQuil® Cold & Flu* Daytime COLD & FLU ACETAMINOPHEN Pain reliever, Fever reducer DEXTROMETHORPHAN HBr Cough suppressant PHENYLEPHRINE HCl Nasal decongestant Relieves: Headache, Fever, Sore throat, Minor aches & pains, Nasal congestion, Sinus pressure, Cough Menthol Flavor Ages 6 Years & Over 2 – 12 FL OZ (355 mL) BOTTLES:

  ♥CVS; Health®

  Compare to the active; ingredients in Vicks®; NyQuil® Cold & Flu*

  Multi-Symptom ; Nighttime; COLD & FLU

  ACETAMINOPHEN ; Pain reliever, Fever reducer; DEXTROMETHORPHAN HBr; Cough suppressant; DOXYLAMINE SUCCINATE; Antihistamine

  Relieves:; Headache, Fever,; Sore throat, Minor aches ; & pains, Sneezing,; Runny nose, Cough

  Cherry; Flavor; Ages 12 Years & Over

  TOTAL 24 FL OZ; (710 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

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

*This product is not manufactured or distributed by The Procter & Gamble
Company, owner of the registered trademarks Vicks® DayQuil® Cold & Flu and
Vicks® NyQuil® Cold & Flu.
50844 ORG032301201302

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-19849

100% money back
guaranteed
CVS.com/returnpolicy

50844
ORG032301201302

CVS 44-012013

INGREDIENTS AND APPEARANCE

COLD AND FLU  DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-123

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-123-02	1 in 1 PACKAGE; Type 0: Not a Combination Product	07/28/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	355 mL
Part 2	1 BOTTLE, PLASTIC	355 mL

Part 1 of 2

COLD AND FLU  DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

Product Information
Item Code (Source)	NDC: 51316-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-120-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2023

Part 2 of 2

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Product Information
Item Code (Source)	NDC: 51316-130
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 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)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red (MAROON)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-130-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2023

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(51316-123) , pack(51316-123)