axiv daytime & nighttime

axiv daytime & nighttime
SPL v2
SPL
SPL Set ID 1320e243-344f-98ed-e063-6294a90a0092
Route
oral
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) acetaminophen (325 mg) doxylamine (15 mg)
Inactive Ingredients
propylparaben methylparaben water gelatin glycerin titanium dioxide povidone k30 polyethylene glycol 400 propylene glycol food yellow 3 free acid fd&c red no. 40 sorbitol fd&c blue no. 1 d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: orange Color: green Size: 22 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-03-08
Description

Day Time Drug Facts

Medication Information

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children 12 years and over

 2 softgels with water every 4 hours

children 4 to under 12 years

 consult a doctor
children under 4 years do not use

Other Information
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

Description

Day Time Drug Facts

Section 42229-5

Day Time

Drug Facts

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg

Pain Reliever-fever reducer
Dextrometrophan HBr 10 mg Cough Suppressant

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
Allergy Alert

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning

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

  • more than 8 Softgels 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
Overdose Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Sore Throat Warning

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

When Using This Product

do not exceed recommended dose

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

Keep out of reach of children.

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Principal Display Panel 48 Caps Day&night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-017-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

32 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

16 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Principal Display Panel 72 Caps Day&night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-018-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

48 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children 12 years and over

 2 softgels with water every 4 hours

children 4 to under 12 years

 consult a doctor
children under 4 years do not use

Other Information (Other information)
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if the foil printed on the blister is torn or ripped
Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

Section 42229-5 (42229-5)

Day Time

Drug Facts

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg

Pain Reliever-fever reducer
Dextrometrophan HBr 10 mg Cough Suppressant

Do Not Use (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
Allergy Alert

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning (Liver warning)

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

  • more than 8 Softgels 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
Overdose Warning (Overdose warning)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Sore Throat Warning (Sore throat warning)

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

When Using This Product (When using this product)

do not exceed recommended dose

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Principal Display Panel 48 Caps Day&night (PRINCIPAL DISPLAY PANEL - 48 Caps Day&Night)

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-017-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

32 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

16 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Principal Display Panel 72 Caps Day&night (PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night)

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-018-01

AXIV

DayTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant

Acetaminophen, Dextromethorphan HBr

48 SOFTGELS** **Liquid-filled capsules



NightTime

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.965079 · Updated: 2026-03-14T23:13:21.652895