SEVERE COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid 
P & L Development, LLC

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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

Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Doxylamine succinate 12.5 mg, Phenylephrine HCI 10 mg

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0416-8237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/31/2015
Labeler - P & L Development, LLC (101896231)

Revised: 4/2024
 
P & L Development, LLC