NITETIME- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

nitetime by

Drug Labeling and Warnings

nitetime by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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 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, 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

Ask a doctor before use if you have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
• trouble urinating due to an 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

• 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: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

• take only as directed – see overdose warning
• do not exceed 4 doses per 24 hours

• adults & children 12 yrs & over:

  2 softgels with water every 6 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• store at 20-25°C (68-77°F)

Inactive Ingredients

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Package/Label Principal Display Panel

nitetime

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DOXYLAMINE SUCCINATE

Pain reliever

Fever reducer

Cough suppressant

Antihistamine

MULTI-SYMPTOM COLD & FLU RELIEF

ACTUAL SIZE

24 SOFTGELS

Compare to the active ingredients in Vicks® NyQuil® Cold & Flu

INGREDIENTS AND APPEARANCE

NITETIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-056
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	GREEN (clear)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	056
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-056-62	12 in 1 CARTON	02/24/2014
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 56062-056-73	8 in 1 CARTON	02/17/2014
2		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	02/17/2014

Labeler - Publix Super Markets Inc (006922009)