Nitetime by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) / P & L Development, LLC Drug Facts

Nitetime by

Drug Labeling and Warnings

Nitetime by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NITETIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 and flu symptoms:

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

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

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

• to make a child sleep
• 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
• glaucoma
• 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

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• avoid alcoholic drinks 
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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: Taking more than the recommended dose can cause liver damage. 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

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in 24 hours
• adults and children 12 years and over: take 2 softgels with water every 6 hours
• swallow whole: do not crush, chew, or dissolve
• children under 12 years: do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat

Inactive ingredients

D&C Yellow #10, edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

call 1-888-309-9030

Principal Display Panel

Compare to the active ingredients in Vicks® Nyquil® Liquicaps® †

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Liquicaps®

Nitetime Cold + flu relief

Pain reliever, Fever reducer: Acetaminophen

Cough suppressant: Dextromethorphan HBr

Antihistamine: Doxylamine Succinate

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Nitetime cold and flu relief softgels

NITETIME  COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-480
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P30;94A;35A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-480-48	4 in 1 CARTON	08/01/2012	03/01/2020
1		12 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	08/01/2012	03/01/2020

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 93a6bbc9-6859-445a-9938-48b60f226a77

34390-5

Set id: 4fe3691e-909e-49bc-9ba3-bfb693a669ac

Version: 2

Effective Time: 20181203

 

Dolgenc