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

Severe DayTime NightTime Cold and Flu Relief by

Drug Labeling and Warnings

Severe DayTime NightTime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by YET HEALTH GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIGHTTIME SEVERE COLD & FLU Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

DAYTIME SEVERE COLD & FLU Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

NIGHTTIME SEVERE COLD & FLU Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

DAYTIME SEVERE COLD & FLU Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

NIGHTTIME SEVERE COLD & FLU Uses

Temporarily relieves common cold/flu symptoms:

• nasal congestion
• sinus congestion and pressure
• cough due to minor throat and bronchial irritation
• cough to help you sleep
• minor aches and pains
• headache
• fever
• sore throat
• runny nose and sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

DAYTIME SEVERE COLD & FLU Uses

Temporarily relieves common cold/flu symptoms:

• nasal congestion
• sinus congestion and pressure
• cough due to minor throat and bronchial irritation
• minor aches and pains
• headache
• fever
• sore throat
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (musus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

• more than 8 softgels 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

NIGHTTIME SEVERE COLD & FLU Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 emphasema
• trouble urinating due to an enlarged prostate gland

DAYTIME SEVERE COLD & FLU Ask a doctor before use if you have

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

NIGHTTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are

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

DAYTIME SEVERE COLD & FLU Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

NIGHTTIME SEVERE COLD & FLU When using this product

• do not exceed recommended dosage
• 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

DAYTIME SEVERE COLD & FLU When using this product

do not use more than directed.

NIGHTTIME SEVERE COLD & FLU Stop use and ask a doctor if

• you gets nervous, dizzy or sleepless
• 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 rash or headache that lasts.

These could be signs of a serious condition.

DAYTIME SEVERE COLD & FLU Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• 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 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.

NIGHTTIME SEVERE COLD & FLU Directions

• take only as directed
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over:

  2 softgels with water every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

DAYTIME SEVERE COLD & FLU Directions

• take only as directed
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over: take 2 softgels with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• store at room temperature; do not exceed 25°C (77°F)

NIGHTTIME SEVERE COLD & FLU Inactive ingredients

D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SODIUM HYDROXIDE, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

DAYTIME SEVERE COLD & FLU Inactive ingredients

FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

Questions?

CALL TOLL-FREE 1-844-735-0202

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81179-804

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81179-804-02	1 in 1 CARTON	09/02/2021
1		1 in 1 BOTTLE; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	40 BOTTLE	40
Part 2	80 BOTTLE	80

Part 1 of 2

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

Product Information
Item Code (Source)	NDC: 81179-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	IS5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81179-004-00	1 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	09/02/2021

Part 2 of 2

SEVERE DAYTIME COLD AND FLU RELIEF  MAX STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

Product Information
Item Code (Source)	NDC: 81179-008
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	IS4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81179-008-00	1 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	09/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/02/2021

Labeler - YET HEALTH GROUP LLC (117763296)