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Severe cold and flu Nighttime by P & L Development, LLC

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: P & L Development, LLC
NDC Code: 49580-0416

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.

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCI 10 mg 

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal Decongestant

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

Warnings

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

  • more than 4,000 mg in 24 hours, which is the maximum daily amount for this product 
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 is 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarges prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed (see overdose warning)
  • 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
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur 
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.

These could be a signs of a serious conditions.

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • take only as directed - see Overdose warning
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing.

Other information
  • each 30 mL contains; sodium 79 mg
  • store between 15-30ºC (59-86ºF)
  • do not refrigerate

Inactive ingredients

anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum 

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

maximum strength

severe night time cold & flu 

cold & flu

Acetaminophen

dextromethorphan HBr

doxylamine succinate

phenylephrine HCI

relieves:

  • aches, fever & sore throat
  • cough
  • runny nose & sneezing
  • nasal & sinus Congestion

alcohol free

berry flavor

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble, distributor or Vicks® NyQuil® Severe Cold & Flu.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL  IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Product Label

Readyincase NightTime Severe Cold & Flu Berry Liquid

SEVERE COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0416
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
ANHYDROUS CITRIC ACID 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
TRISODIUM CITRATE DIHYDRATE 
GLYCERIN 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-0416-8237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/31/2015
Labeler - P & L Development, LLC (101896231)

 
P & L Development, LLC

← See all Severe cold and flu Nighttime brands

Medically reviewed on Oct 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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