SHOP RITE DAY SEVERE COLD NIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit

shop rite Day Severe Cold Night Cold and Flu by

Drug Labeling and Warnings

shop rite Day Severe Cold Night Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each liquid gel) – DAY Severe Cold

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes – DAY Severe Cold

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active ingredients (in each liquid gel) – NIGHT Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes – NIGHT Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
• cough
• minor aches and pains
• headache
• nasal congestion
• sore throat
• runny nose and sneezing (NIGHT only)
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
• controls cough to help you get to sleep (NIGHT only)
• temporarily reduces fever

Warnings

Liver warning: These products contain 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 these products

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 these products.
• if you have ever had an allergic reaction to these products or any of their ingredients

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 (NIGHT only)
• a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

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

When using these products

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

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 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.

Overdose warning: 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.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 10 liquid gels in any 24-hour period
• adults and children 12 years of age and older: take 2 liquid gels every 4 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients (DAY only)

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients (NIGHT only)

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

FAST DISSOLVING LIQUID GELS

MAXIMUM STRENGTH

Compare To Mucinex® Fast-Max® Day Severe Cold & Night Cold & Flu active ingredients

DAY

SEVERE COLD

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

Actual Size

FOR AGES 12+

16 LIQUID GELS

(Liquid Filled Capsules)

NIGHT

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Doxylamine Succinate – Antihistamine

Phenylephrine HCl – Nasal Decongestant

Relieves Aches, Fever & Sore Throat

Controls Cough

Relieves Nasal Congestion

Relieves Runny Nose & Sneezing

Actual Size

8 LIQUID GELS

(Liquid Filled Capsules)

INGREDIENTS AND APPEARANCE

SHOP RITE DAY SEVERE COLD NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-609

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-609-90	1 in 1 CARTON; Type 0: Not a Combination Product	02/28/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	8 BLISTER PACK	16
Part 2	4 BLISTER PACK	8

Part 1 of 2

SHOP RITE DAY SEVERE COLD 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

Product Information
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	7G0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 KIT
1		2 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	02/28/2018

Part 2 of 2

SHOP RITE NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product Information
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	345
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 KIT
1		2 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	02/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/28/2018

Labeler - Shopko Stores Operating Co., LLC (023252638)