COLD MAX NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid 
P & L Development, 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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Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg 

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • 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
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dose (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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 lasts more than 3 days
  • redness or swelling is present 
  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Other information

Inactive ingredients

citric acid, ethyl alcohol, FD&C blue #1, flavors, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Principal Display Panel

*Compare to the active ingredients in Tylenol® Cold Max Nighttime Cool Burst

nighttime

cold max

Acetaminophen

dextromethorphan HBr 

doxylamine Succinate

phenylephrine HCI

For ages 12 years and over

alcohol 0.5%

cool blast flavor

relieves:

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol®Cold Max Nighttime Cool Burst®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Product Label

Acetaminophen 325 mg, Dextromethorphan Hbr 10 mg, Doxylamine Succinate 6.25 mg, Phenylephrine HCI 5 mg

ReadyinCase Nighttime Cold Max Cool Blast Flavor

COLD MAX  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-0515-8237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201610/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/201610/31/2024
Labeler - P & L Development, LLC (101896231)

Revised: 5/2023
Document Id: 90edca1e-5b90-43a0-973e-f07a3062e4fa
Set id: dac0d878-2288-4b55-8691-7f9f16e6d341
Version: 3
Effective Time: 20230517
 
P & L Development, LLC