Axim Daytime & Night Time

Axim Daytime & Night Time
SPL v10
SPL
SPL Set ID de9eb2d5-ba51-4637-e053-2995a90a0451
Route
ORAL
Published
Effective Date 2022-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 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: axim Shape: oval Color: orange Color: green Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-05-09 Until 2025-08-20

Description

Day Time Drug Facts


Medication Information

Description

Day Time Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5

Day Time

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Pain Reliever-fever reducer

Dextrometrophan HBr 10 mg Cough Suppressant
Phenylephrine HCl 5 mg Nasal Decongestant

Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children over 12 years

2 softgels with water every 4 hours

children 4 to under 12 years

consult a doctor
children under 4 years 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

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Other Information
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if carton is open or blister unit is broken.
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.

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

When Using This Product

do not exceed recommended dose

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • 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 82706-003-01



Day Time

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

32 SOFTGELS** **Liquid-filled capsules



Night Time

  • 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 82706-004-01

Day Time

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

48 SOFTGELS** **Liquid-filled capsules



Night Time

  • 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:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5 (42229-5)

Day Time

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Pain Reliever-fever reducer

Dextrometrophan HBr 10 mg Cough Suppressant
Phenylephrine HCl 5 mg Nasal Decongestant

Directions
  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children over 12 years

2 softgels with water every 4 hours

children 4 to under 12 years

consult a doctor
children under 4 years do not use

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 4,000 mg of acetaminophen in 24 hours
  • 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.

Other Information (Other information)
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper evident: Do not use if carton is open or blister unit is broken.
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.

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

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)
  • you get nervous, dizzy or sleepless
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • 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 82706-003-01



Day Time

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

32 SOFTGELS** **Liquid-filled capsules



Night Time

  • 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 82706-004-01

Day Time

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

48 SOFTGELS** **Liquid-filled capsules



Night Time

  • 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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