MULTI-SYMPTOM DAYTIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

MULTI-SYMPTOM DAYTIME by

Drug Labeling and Warnings

MULTI-SYMPTOM DAYTIME by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches/pains
• fever

Warnings

Liver warning

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

• more than 4 doses 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

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

When using this product

• do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• pain, nasal congestion or cough gets 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.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Directions

• Take only as directed—see Overdose warning.
• do not exceed 4 doses per 24 hours.

• adults and children 12 years of age and over: swallow 2 softgels with water every 4 hours
• children 4 to under 12 years of age: ask a doctor
• children under 4 years of age: do not use

If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing

Other information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
• this product does not contain phenylpropanolamine

Inactive ingredients

FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton

COMPARE TO ACTIVE INGREDIENTS IN
VICKS ® DAYQUIL ®*

ASSURED™

MULTI-SYMPTOM

DayTime
Liquid Capsules

• Acetaminophen - Pain Reliever / Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Phenylephrine HCl - Nasal Decongestant

Fever, Headache, Sore Throat,
Coughing, Minor Aches and Pains,
& Nasal Congestion

Actual Size

10 softgels

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM DAYTIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0104
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE (SOFTGELS)	Size	21mm
Flavor		Imprint Code	512
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0104-1	1 in 1 CARTON	02/20/2016
1		10 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	02/20/2016

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(68210-0104)