MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA- acetaminophen, dextromethorphan, phenylephrine hcl kit

MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA by

Drug Labeling and Warnings

MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS - DAY MAXIMUM STRENGTH COLD AND FLU (633T)

DAY MAXIMUM STRENGTH COLD AND FLU

ACTIVE INGREDIENT

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

INACTIVE INGREDIENT

Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

PURPOSE

Purposes:

• Pain reliever/fever reducer
• Cough suppressant
• Nasal decongestant

DOSAGE & ADMINISTRATION

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

INDICATIONS & USAGE

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

Nasal Decongestant

• Nasal Congestion
• Headache & Body Ache
• Cough
• Runny Nose
• Sore Throat

WARNINGS

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 or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 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.

DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU

NIGHT MAXIMUM STRENGTH COLD AND FLU

ACTIVE INGREDIENT

Active ingredeints in each softgel

ACETAMINOPHEN 325 mg

Dextromethorphan Hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

INACTIVE INGREDIENT

Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide

PURPOSE

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

/Nasal Decongestant

INDICATIONS & USAGE

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

DOSAGE & ADMINISTRATION

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

KEEP OUT OF REACH OF CHILDREN

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.

WARNINGS

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 aloholic drinks every day while using this product

l Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA 
acetaminophen, dextromethorphan, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-935

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-935-02	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/02/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	8

Part 1 of 2

MAXIMUM STRENGHT DAY COLD AND FLU FORMULA 
acetaminophen, dextromethorphan, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 55319-933
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	70
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-933-22	12 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 final	part341	08/20/2020

Part 2 of 2

MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 55319-934
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	72
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-934-08	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 final	part341	08/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/02/2020

Labeler - FAMILY DOLLAR (024472631)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(55319-935)