CVS DT AND NT COMBO PACK COLD AND FLU- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit

CVS DT and NT Combo Pack by

Drug Labeling and Warnings

CVS DT and NT Combo Pack by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CVS DayTime Cold & Flu Relief

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/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• minor aches & pains
• headache
• fever
• sore throat

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

• adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
• 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.

Ask a doctor before use if you have

• Liver disease
• Heart disease
• High blood pressure
• Thyroid disease
• Diabetes
• Trouble urinating due to enlarged prostate gland
• Cough that occurs with too much phlegm (mucus)
• Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• A sodium-restricted diet

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adult)
• 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• Only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  30 mL every 4 hours

• Children 6 to under 12 yrs:

  15 mL every 4 hours

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

each 15 mL contains:

• sodium 42 mg
• store at room temperature
• Do not refrigerate.

Inactive ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions?

1-866-467-2748

SPL UNCLASSIFIED SECTION

CVSNIGHTTIME COLD & FLU RELIEF

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/flu symptoms:

• cough due to minor throat & bronchial irritation
• minor aches & pains
• headache
• fever
• sore throat
• runny nose & sneezing

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• taken 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.

Ask a doctor before use if you have

• Liver disease
• glaucoma
• Trouble urinating due to enlarged prostate gland
• Cough that occurs with too much phlegm (mucus)
• A breathing problem 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

• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• Only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  30 mL every 4 hours

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• each 30 mL contains: sodium 16 mg
• Store at room temperature
• Do not refrigerate

Inactive ingredients

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

SPL UNCLASSIFIED SECTION

Distributed By:

PRINCIPAL DISPLAY PANEL - Kit Carton

Compare to the active ingredients in Vicks®DayQuil™ Cold & Flu*

NDC# 51316-618-12

DayTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr,

Phenylephrine HCl

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal Congestion & Sinus Pressure
• Cough

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

NightTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr

Dextromethorphan HBr

• headache, Fever, Sore Throat,
• Minor Aches & Pains
• Sneezing, Runny Nose
• Cough

Original Flavor

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)

*These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ and Vicks® Nyquil™ Cold & flu.

INGREDIENTS AND APPEARANCE

CVS DT AND NT COMBO PACK   COLD AND FLU
acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-618

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-618-12	1 in 1 PACKAGE; Type 0: Not a Combination Product	03/20/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	354 mL
Part 2	1 BOTTLE	354 mL

Part 1 of 2

CVS DAYTIME COLD AND FLU   RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid

Product Information
Item Code (Source)	NDC: 51316-620
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-620-12	354 mL in 1 BOTTLE; 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	03/20/2023

Part 2 of 2

CVS NIGHTTIME COLD AND FLU   RELIEF
acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide liquid

Product Information
Item Code (Source)	NDC: 51316-619
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-619-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	03/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/20/2023

Labeler - CVS PHARMACY (062312574)