COLD AND FLU SEVERE NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled 
TOPCO ASSOCIATES LLC

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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Cold and Flu Severe Nighttime

Drug Facts

Active ingredients (in each softgel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels 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, 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a sodium-restricted diet
  • trouble urinating due to enlarged prostate gland
  • 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

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

  • you get nervous, dizzy or sleepless
  • 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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults & children 12 yrs & over2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions?

Call toll free: 1-888-423-0139

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

NDC: 36800-827-24

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

MAXIMUM STRENGTH RELIEF
Night Time
Cold & Flu Relief
SEVERE

PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
NASAL DECONGESTANT - PHENYLEPHRINE HCl

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Runny Nose & Sneezing • Cough

24 SOFTGELS

actual size

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
COLD AND FLU SEVERE NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-848
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
Doxylamine Succinate (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) Doxylamine Succinate6.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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 K30 (UNII: U725QWY32X)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint Code 789
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-848-242 in 1 CARTON05/01/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 1/2023
Document Id: c2cccf0d-9e00-4cdf-a82c-fa3ad895efe8
Set id: c53add02-d82f-4fb8-8ccf-43902e7bfb99
Version: 2
Effective Time: 20230118
 
TOPCO ASSOCIATES LLC