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Lil Drug Store NyQuil Severe Cold and Flu, Max Strength

Medically reviewed on March 6, 2017

Dosage form: tablet, coated
Ingredients: Acetaminophen 325mg, Phenylephrine Hydrochloride 5mg, Doxylamine Succinate 6.25mg, Dextromethorphan Hydrobromide 10mg
Labeler: Lil Drug Store Products, Inc
NDC Code: 66715-9705

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.

Lil' Drug Store® NyQuil® Severe
Cold & Flu, Max Strength

Drug Facts

Active ingredients (in each caplet)Purpose
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:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Warnings

Liver warning

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

  • more than 4 doses 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
  • 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
  • trouble urinating due to 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
  • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

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
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information
  • store at room temperature

Inactive ingredients

crospovidone, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, magnesium stearate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions?

1-800-362-1683

PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:
LIL' DRUG STORE PRODUCTS, INC., 1201 CONTINENTAL PLACE NE, CEDAR RAPIDS, IA 52402

PRINCIPAL DISPLAY PANEL - 4 Caplets Pouch Carton

MAX
STRENGTH

VICKS®

NyQuil®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

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

Nighttime Relief

4
Caplets

Lil'
Drug Store®

LIL DRUG STORE NYQUIL SEVERE   COLD AND FLU, MAX STRENGTH
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9705(NDC:37000-813)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Doxylamine Succinate (Doxylamine) Doxylamine Succinate6.25 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Inactive Ingredients
Ingredient NameStrength
Crospovidone (15 MPA.S AT 5%) 
D&C Yellow No. 10 
FD&C Blue No. 1 
FD&C Yellow No. 6 
Magnesium Stearate 
Mica 
Microcrystalline Cellulose 
Polyethylene Glycol, Unspecified 
Polysorbate 80 
Polyvinyl Alcohol, Unspecified 
Povidone, Unspecified 
Stearic Acid 
Talc 
Titanium Dioxide 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize19mm
FlavorImprint CodeNQ
Contains    
Packaging
#Item CodePackage Description
1NDC:66715-9705-22 POUCH in 1 CARTON
12 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/07/2016
Labeler - Lil Drug Store Products, Inc (093103646)

 
Lil Drug Store Products, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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