COLD AND FLU NIGHTTIME RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Cold and Flu Nighttime Relief by

Drug Labeling and Warnings

Cold and Flu Nighttime Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each liquid-filled capsule)

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
  • minor aches and pains
    
  • headache
  • 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
  

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

• 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
• to make a child sleepy
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• glaucoma
  
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  
• cough that occurs with too much phlegm (mucus)
  
• difficulty in urination due to enlargement of the prostate gland
  

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 beverages
• marked drowsiness may occur
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• use caution 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  
• do not take more than 8 capsules per 24 hours
  
• adults and children 12 years and over: take 2 capsules with water every 6 hours
• children under 12 years: ask a doctor
  

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• protect from heat, humidity and light
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-844-428-2538

Principal display panel

24/7 Life
by 7-Eleven™

Multi-Symptom
Cold&Flu
Nighttime Relief

Acetaminophen / Pain Reliever/Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine

Relieves:
Headache, Fever
Sore Throat,
Cough, Sneezing,
Runny Nose

16 
LIQUID-FILLED
CAPSULES

Actual Size

compare to Vicks®
NyQuil® Cold &
Flu LiquiCaps®
active ingredient*

QUALITY
GUARANTEED

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Satisfaction Guaranteed 1-800-255-0711

DISTRIBUTED BY 7-ELEVEN, INC., IRVING, TX 75063

WWW.7-ELEVEN.COM

Product of China
Packaged and Quality Assured in the USA

*This product is not manufactured or distributed by The Procter
& Gamble Company, owner of the registered trademark Vicks®
NyQuil® Cold & Flu LiquiCaps®.

50844 ORG041866021

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

CV 44-660

INGREDIENTS AND APPEARANCE

COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-266
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)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN (clear)	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	660
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-266-21	2 in 1 CARTON	07/30/2019
1		8 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	07/30/2019

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-266)