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Nighttime cold and flu by Geiss, Destin & Dunn, Inc (Goodsense)

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Geiss, Destin & Dunn, Inc (Goodsense)
NDC Code: 50804-480

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 softgel)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose and sneezing

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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
  • to make a child sleep

Ask a doctor before use if you have
  • liver disease
  • 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
  • pain 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.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over swallow 2 softgels with water every 6 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

D&C Yellow #10, edible white printing ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol NF, povidone, propylene glycol, purified water, sorbitan, and sorbitol

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredients in Vicks® Nyquil®

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil®

Nighttime Cold & flu

  • Sore throat pain
  • Minor aches and pains
  • fever
  • cough headache
  • runny nose and sneezing

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree city, GA 30269

www.valuelabels.com

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Nighttime cold and flu

NIGHTTIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-480
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeP30;94A;35A
Contains    
Packaging
#Item CodePackage Description
1NDC:50804-480-162 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
18 CAPSULE, LIQUID FILLED (8 CAPSULE) in 1 BLISTER PACK
2NDC:50804-480-242 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
212 CAPSULE, LIQUID FILLED (12 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2012
Labeler - Geiss, Destin & Dunn, Inc (Goodsense) (076059836)

 
Geiss, Destin & Dunn, Inc (Goodsense)

← See all Nighttime cold and flu brands

Medically reviewed on Oct 18, 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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