ALKA-SELTZER PLUS NIGHT SEVERE COLD, COUGH AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder 
Bayer HealthCare 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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Alka-Seltzer Plus ® Night Severe Cold, Cough & Flu

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Diphenhydramine hydrochloride 25 mgAntihistamine/Cough suppressant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose and throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever

Warnings

Liver warning

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

  • more than 5 packets 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use to sedate children.

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a breathing problem such as emphysema, asthma or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

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 dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • pain, cough, or nasal congestion 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.
  • nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

  • do not take more than the recommended dose
  • take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

  • each packet contains: potassium 10 mg, sodium 24 mg
  • Phenylketonurics: Contains Phenylalanine 13 mg Per Packet
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NEW!
Mix-In Packets

Alka-
Seltzer
PLUS
®
Acetaminophen / Pain
reliever-fever reducer
Phenylephrine HCl / Nasal decongestant
Diphenhydramine HCl / Antihistamine/
cough suppressant

Honey Lemon Zest
Fast Relief Mix-In Packets

NIGHT
SEVERE
COLD, COUGH & FLU

Nasal Congestion • Runny Nose • Cough
Headache + Body Ache • Sore Throat

6 PACKETS

PRINCIPAL DISPLAY PANEL - 6 Packet Carton
ALKA-SELTZER PLUS NIGHT SEVERE COLD, COUGH AND FLU 
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Colorwhite (white, yellow-orange & dark particles) Score    
ShapeSize
FlavorHONEY (Honey Lemon Zest) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1158-066 in 1 CARTON07/31/201205/01/2014
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/201205/01/2014
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2017
 
Bayer HealthCare LLC.