MULTI-SYMPTOM NITETIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

MULTI-SYMPTOM NITETIME by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each softgel)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mg	Cough suppressant
Doxylamine Succinate 6.25 mg	Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches/pains
• fever
• runny nose and sneezing

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

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, lasts for more than 2 days, or 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.
• to make a child sleep

Ask a doctor before use if you have

• liver disease
• 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 emphysema
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not use more than directed
• 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

Stop use and ask a doctor if

• pain 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

Overdose warning: Taking more than the recommended dose 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 as well as for children, even if you do not notice any signs or symptoms.

Directions

• Take only as recommended—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 6 hours
  • children 4 to under 12 years of age: ask a doctor
  • children under 4 years of age: do not use

If taking Nighttime and Daytime 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

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

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Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 48 COUNT BLISTER CARTON

VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients

in VICKS® NyQUIL®*

MULTI-SYMPTOM

NITE TIME

COLD&FLU NIGHTTIME RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE

• Pain Reliever
• Fever Reducer
• Cough Suppressant
• Antihistamine

48 SOFTGELS

Liquid filled capsules

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM NITETIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1050
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	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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	green	Score	no score
Shape	CAPSULE (SOFTGELS)	Size	20mm
Flavor		Imprint Code	215
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1050-0	48 in 1 CARTON	04/16/2018
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68210-1050-1	1 in 1 CARTON	04/16/2018
2		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	04/16/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(68210-1050)