SPL v1
SPL
SPL Set ID e8538d9c-f9ba-40b1-b60f-f57921f39b64
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Crospovidone Fd&c Yellow No. 6 Maltodextrin Silicon Dioxide Povidone Starch, Corn Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Polyvinyl Alcohol, Unspecified Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;546 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan Hydrobromide 10 mg Guaifenesin 100 mg Phenylephrine Hydrochloride 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan Hydrobromide 10 mg Guaifenesin 100 mg Phenylephrine Hydrochloride 5 mg

Section 42229-5

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
Stop Use

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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.

Warnings

Warnings

Questions

Questions or comments? (888) 602-0288

Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 have ever had an allergic reaction to this product or any of its ingredients
  • 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.
When Using

When using this product do not exceed recommended dosage.

Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Inactive Ingredient

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Indications & Usage

Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Ask Doctor/pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Dosage & Administration

Directions

  • do not take more than directed

Adults and children: (12 years and over)

  • take 2 caplets every 4 hours
  • not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Other Safety Information

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Pregnancy 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel – 150 Tablet Box Label

Cold Terminator

Maximum Strength

Cold Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pull to Open

RELIEVES

  • Fever
  • Pain
  • Stuffy Nose
  • Chest Congestion

The Provision

First Aid

Line™

BY WILDMAN

150 Caplets

2 per packet


Structured Label Content

Section 42229-5 (42229-5)

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
Purpose (PURPOSE)

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Stop Use (STOP USE)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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.

Warnings (WARNINGS)

Warnings

Questions (QUESTIONS)

Questions or comments? (888) 602-0288

Ask Doctor (ASK DOCTOR)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 have ever had an allergic reaction to this product or any of its ingredients
  • 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.
When Using (WHEN USING)

When using this product do not exceed recommended dosage.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Indications & Usage (INDICATIONS & USAGE)

Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

  • do not take more than directed

Adults and children: (12 years and over)

  • take 2 caplets every 4 hours
  • not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Other Safety Information (OTHER SAFETY INFORMATION)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Pregnancy Or Breast Feeding (PREGNANCY 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel – 150 Tablet Box Label (PRINCIPAL DISPLAY PANEL – 150 Tablet Box Label)

Cold Terminator

Maximum Strength

Cold Relief

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pull to Open

RELIEVES

  • Fever
  • Pain
  • Stuffy Nose
  • Chest Congestion

The Provision

First Aid

Line™

BY WILDMAN

150 Caplets

2 per packet


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)