SEVERE NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated

Severe Nighttime Cold and Flu Relief by

Drug Labeling and Warnings

Severe Nighttime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
    
  • sore throat
  • fever
  • headache
  • nasal congestion
    
  • cough due to minor throat and bronchial irritation
    
  • runny nose and sneezing
    
• reduces swelling of nasal passages
  
• promotes nasal and/or sinus drainage
• temporarily restores freer breathing through the nose

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:

• blisters
• rash
• skin reddening
  

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

• 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
• diabetes
• thyroid disease
  
• heart disease
• glaucoma
• high blood pressure
  
• difficulty in urination due to enlargement of the prostate gland
  
• 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)

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 exceed recommended dosage
  
• excitability may occur, especially in children
  
• marked drowsiness may occur
  
• avoid alcoholic beverages
  
• be careful when driving a motor vehicle or operating machinery
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
  
• pain, nasal congestion, 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 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 caplets in 24 hours
  
• adults and children 12 years and over: take 2 caplets with water every 4 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
  
• 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

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid,
talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

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

Maximum Strenght

SEVERE NIGHTTIME
COLD & FLU RELIEF

ACETAMINOPHEN
DEXTROMETHORPHAN HBr
DOXYLAMINE SUCCINATE  PHENYLEPHRINE HCl

PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT  ANTIHISTAMINE  NASAL DECONGESTANT

Relieves headache, fever, sore throat,
minor aches & pains, nasal/sinus congestion
& sinus pressure, sneezing, runny nose, cough

Actual Size

24 CAPLETS

RITE 
AID®
PHARMACY

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

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

50844 ORG051967708

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied,
we'll happily refund your money.

Rite Aid 44-677

INGREDIENTS AND APPEARANCE

SEVERE NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0677
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;677
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0677-8	2 in 1 CARTON	12/10/2019
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	12/10/2019

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(11822-0677)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(11822-0677)