Nighttime Cold Multi-Symptom by AmerisourceBergen (Good Neighbor Pharmacy) 46122 Drug Facts

Nighttime Cold Multi-Symptom by

Drug Labeling and Warnings

Nighttime Cold Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen (Good Neighbor Pharmacy) 46122. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIGHTTIME COLD MULTI-SYMPTOM COOL BLAST- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid 
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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, 1 tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves these common cold symptoms:

  • sore throat
  • headache
  • minor aches and pains
  • cough
  • sneezing
  • nasal congestion
  • runny nose
  • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you get rest
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more aloholic drinks daily while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fevere, 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.
  • 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking

  • the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product,

  • do not exceed recommended dose (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 fever, 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 recommneded dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • use dosage cup provided. Do not use any other dosing device
  • tbsp=tablespoon, mL= milliliter
Age Dose
adults and children 12 years and over
  • take 2 tablespoons (30 mL) in dose cup provided every 4 hours
  • do not take more than 12 tablespoons (180 mL) in 24 hours
children under 12 years
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • each tablespoon contains: sodium 5 mg
  • store at room temperature
  • dosage cup provided

Inactive ingredients

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

Principal Display Panel

*Compare to the active ingredients in Tylenol® Cold Multi-Symptom Nighttime 

Nighttime 

Cold Multi-Symptom

Cool Blast

Acetaminophen- Pain reliever, fever reducer

Dextromethorphan HBr-Cough suppressant

Doxylamine succinate-Antihistamine

Phenylephrine HCl-Nasal decongestant

Cool Mint Flavor

FL OZ (mL)

Alcohol 0.5%

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Cold Multi-Symptom Nighttime.

Distributed by: AmerisourceBergen

1300 Morris Drive Chesterbrook, PA 19087

www.goodneighborpharmacy.com

Questions or comments? 1-866-534-4631

Package Label

Acetamnophen 325 mg, Dextromethorphan HBr 10 mg, doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Quality Choice Nighttime Cold Multi-Symptom

NIGHTTIME COLD MULTI-SYMPTOM  COOL BLAST
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46122-034
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)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46122-034-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/201112/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/04/201112/31/2019
Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 12/2018
 
AmerisourceBergen (Good Neighbor Pharmacy) 46122