1150-qch-2024-0807

1150-qch-2024-0807
SPL v2
SPL
SPL Set ID a92bcefb-ba29-4b3f-a60b-b4476ca8cf04
Route
ORAL
Published
Effective Date 2024-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Acesulfame Potassium Silicon Dioxide Croscarmellose Sodium Crospovidone Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol Povidone Starch, Pregelatinized Corn Propylene Glycol Stearic Acid Talc Titanium Dioxide Fd&c Blue No. 1 Aluminum Oxide

Identifiers & Packaging

Pill Appearance
Imprint: AAA;1139 Shape: oval Color: white Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-07

Description

COLD MAX DAY


Medication Information

Description

COLD MAX DAY

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever
Section 42229-5

COLD MAX DAY

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients (in each Day caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Directions
  • do not take more than directed (see overdose warning)
  • do not take Day and Night caplets at the same time
  • do not take more than a total of 10 caplets in 24 hours
adults and children

12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
children under

12 years
  • ask a doctor

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
Cold Max Day

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
Cold Max Night

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information and warnings
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.

Principal Display Panel

QUALITY CHOICE®

NDC 83324-093-20

Cold Max Day & Night

For Adults

Acetaminophen,Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate*

Pain Reliever | Fever Reducer, Cough Suppressant, Nasal Decongestant, Antihistamine*

For Relief of:

Headache + Body Aches

Fever + Sore Throat

Nasal Congestion

Cough

Runny Nose*

*Antihistamine in Nighttime Only

12 DAY / 8 NIGHT CAPLETS

DAY Actual Size

NIGHT Actual Size

20 COOL TASTE CAPLETS

When Using This Product
  • do not exceed recommended dosage

In addition, when using Cold Max Night:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever
Section 42229-5 (42229-5)

COLD MAX DAY

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each Day caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Directions
  • do not take more than directed (see overdose warning)
  • do not take Day and Night caplets at the same time
  • do not take more than a total of 10 caplets in 24 hours
adults and children

12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
children under

12 years
  • ask a doctor

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
Cold Max Day

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
Cold Max Night

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information and warnings
Sore Throat Warning (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

QUALITY CHOICE®

NDC 83324-093-20

Cold Max Day & Night

For Adults

Acetaminophen,Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate*

Pain Reliever | Fever Reducer, Cough Suppressant, Nasal Decongestant, Antihistamine*

For Relief of:

Headache + Body Aches

Fever + Sore Throat

Nasal Congestion

Cough

Runny Nose*

*Antihistamine in Nighttime Only

12 DAY / 8 NIGHT CAPLETS

DAY Actual Size

NIGHT Actual Size

20 COOL TASTE CAPLETS

When Using This Product (When using this product)
  • do not exceed recommended dosage

In addition, when using Cold Max Night:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
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
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)