Label: ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution
- NDC Code(s): 0280-0922-06
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 16, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- 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 have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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
- may cause marked drowsiness
- avoid alcoholic drinks
- 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
- 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
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 6 Packet Carton
Alka-Seltzer PLUS ®
Cold & Flu
Honey Lemon Zest
Fast Relief Mix-In Packets
Acetaminophen / Pain reliever-fever reducer
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant
Dextromethorphan HBr / Cough suppressant
• Nasal Congestion
• Sore Throat
• Body Ache
• Runny Nose
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0922 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SUCRALOSE (UNII: 96K6UQ3ZD4) TARTARIC ACID (UNII: W4888I119H) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) SUCROSE (UNII: C151H8M554) MENTHOL (UNII: L7T10EIP3A) LEMON (UNII: 24RS0A988O) HONEY (UNII: Y9H1V576FH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color yellow Score Shape Size Flavor LEMON, HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0922-06 6 in 1 CARTON 04/17/2014 1 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/17/2014 Labeler - Bayer HealthCare LLC. (112117283) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corp. 968335112 manufacture(0280-0922) , pack(0280-0922)