DAYTIME AND NIGHTTIME HIGH BLOOD PRESSURE COLD AND FLU LIQUID- acetaminophen, dextromethorphan hbr and acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Daytime and Nighttime High Blood Pressure Cold and Flu Liquid by

Drug Labeling and Warnings

Daytime and Nighttime High Blood Pressure Cold and Flu Liquid by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., Time Cap Laboratories, Inc., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Daytime High Blood Pressure Cold & Flu

ACTIVE INGREDIENT

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Cough suppressant

INDICATIONS & USAGE

Uses temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever

WARNINGS

Warnings

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

• more than 4 doses (30 mL each dose) in 24 hours, which is the maximum daily amount for this product
• 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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

Stop use and ask a doctor if

• pain or cough get worse or last 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

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 per dose every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

OTHER SAFETY INFORMATION

Other information

• each 30 mL contains: sodium 30 mg
• store at no greater than 25℃ and do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, FD&C yellow no. 6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

QUESTIONS

Questions or comments? Call 1-877-290-4008

Drug Facts Nighttime High Blood Pressure Cold & Flu

ACTIVE INGREDIENT

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE

Uses temporarily relieves common cold/flu symptoms:

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

WARNINGS

Warnings

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

• more than 4 doses (30 mL each dose) in 24 hours, which is the maximum daily amount for this product
• 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
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to enlarged prostate gland

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, and 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

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 per dose every 6 hrs

  • children 4 to under 12 yrs:

    ask a doctor

  • children under 4 yrs:

    do not use

OTHER SAFETY INFORMATION

Other information

• each 30 mL contains: sodium 30 mg
• store at no greater than 25℃ and do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME HIGH BLOOD PRESSURE COLD AND FLU LIQUID 
acetaminophen, dextromethorphan hbr and acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-666

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-666-07	1 in 1 PACKAGE; Type 0: Not a Combination Product	04/21/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	236 mL
Part 2	1 BOTTLE	236 mL

Part 1 of 2

NIGHTTIME HIGH BLOOD PRESSURE COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC: 51316-664
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	red (Clear red color solution)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-664-06	236 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	04/21/2025

Part 2 of 2

DAYTIME HIGH BLOOD PRESSURE COLD AND FLU 
acetaminophen, dextromethorphan hbr liquid

Product Information
Item Code (Source)	NDC: 51316-665
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	20 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	orange (Clear orange color solution)	Score
Shape		Size
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-665-06	236 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	04/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/21/2025

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Time Cap Laboratories, Inc. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(51316-666)