Label: ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution
- NDC Code(s): 0280-0921-06
- 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 6 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
- 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
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough with excessive phlegm (mucus)
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 6 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 ®
Severe Cold & Flu
Honey Lemon Zest
Fast Relief Mix-In Packets
Acetaminophen / Pain reliever-fever reducer
Phenylephrine HCl / Nasal decongestant
Dextromethorphan HBr / Cough suppressant
Guaifenesin / Expectorant
• Nasal Congestion
• Sore Throat
• Body Ache
• Chest Congestion
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0921 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) LEMON (UNII: 24RS0A988O) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) POVIDONE (UNII: FZ989GH94E) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TARTARIC ACID (UNII: W4888I119H) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HONEY (UNII: Y9H1V576FH) 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:0280-0921-06 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(0280-0921) , pack(0280-0921)