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

MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU by

Drug Labeling and Warnings

MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each softgel)
Daytime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Active ingredients (in each softgel)
Nighttime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

PURPOSE

Purposes
Daytime Cold & Flu
Pain reliever/fever reducer

Cough suppressant
Expectorant
Nasal decongestant

Purposes
Nighttime Cold & Flu
Pain reliever/fever reducer
Cough suppressant

Antihistamine
Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves these common cold and flu symptoms:

- sinus congestion and pressure
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose and sneezing ( Nighttime only)
- itchy, watery eyes due to hay fever ( Nighttime only)
- itching of the nose or throat ( Nighttime only)

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ( Daytime only)
• controls cough to help you get to sleep
• temporarily reduces fever

WARNINGS

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

• more than 12 softgels in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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

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 DOCTOR

Ask a doctor before use if you have

• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• glaucoma ( Nighttime only)
• breathing problems such as emphysema or chronic bronchitis ( Nighttime only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers ( Nighttime only)

WHEN USING

When using this product

• do not use more than directed
• excitability may occur, especially in children ( Nighttime only)
• marked drowsiness may occur ( Nighttime only)
• alcohol, sedatives, and tranquilizers may increase drowsiness ( Nighttime only)
• avoid alcoholic drinks ( Nighttime only)
• be careful when driving a motor vehicle or operating machinery ( Nighttime only)

STOP USE

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, 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 fever, rash, or headache that lasts.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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

• do not take more than directed (see Overdose warning)
• do not take more than 12 softgels in any 24-hour period
• adults and children 12 years of age and over: take 2 softgels every 4 hours
• children under 12 years of age: do not use

OTHER INFORMATION

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients (Daytime only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Inactive ingredients (Nighttime only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

QUESTIONS

Questions or comments? C all 1-877-290-4008

PRINCIPAL DISPLAY PANEL

CVS 630T Daytime Nighttime Cold & Flu

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-451

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-451-24	1 in 1 CARTON	07/10/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	16
Part 2	1 BLISTER PACK	8

Part 1 of 2

MAXIMUM STRENGTH DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 69842-094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	78
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-094-16	16 in 1 BLISTER PACK; 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	07/10/2021

Part 2 of 2

MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 69842-382
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	72
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-382-08	8 in 1 BLISTER PACK; 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	07/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/10/2021

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(69842-451)