634t - Family Dollar Day-night Maximum Strength Cold And Flu 55319-935

634t - Family Dollar Day-night Maximum Strength Cold And Flu 55319-935
SPL v4
SPL
SPL Set ID aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a
Route
ORAL
Published
Effective Date 2021-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Shellac Titanium Dioxide Fd&c Yellow No. 6 Fd&c Red No. 40 Propylene Glycol Water Sorbitol Polyethylene Glycol, Unspecified Povidone Gelatin Glycerin Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 72 Shape: oval Color: orange Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-02

Description

DAY MAXIMUM STRENGTH COLD AND FLU


Medication Information

Warnings and Precautions

Warnings

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

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

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

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.

Indications and Usage

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Runny Nose
  • Sore Throat
Dosage and Administration

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Description

DAY MAXIMUM STRENGTH COLD AND FLU

Section 50565-1

Keep out of reach of children. 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.

Section 51727-6

Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 55105-1

Purposes:

  • Pain reliever/fever reducer
  • Cough suppressant
  • Nasal decongestant
Section 55106-9

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Drug Facts Night Maximum Strength Cold and Flu

NIGHT MAXIMUM STRENGTH COLD AND FLU

Drug Facts Day Maximum Strength Cold and Flu (633t)

DAY MAXIMUM STRENGTH COLD AND FLU


Structured Label Content

Indications and Usage (34067-9)

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

Nasal Decongestant

  • Nasal Congestion
  • Headache & Body Ache
  • Cough
  • Runny Nose
  • Sore Throat
Dosage and Administration (34068-7)

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Warnings and Precautions (34071-1)

Warnings

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

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

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

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.

Section 50565-1 (50565-1)

Keep out of reach of children. 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.

Section 51727-6 (51727-6)

Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purposes:

  • Pain reliever/fever reducer
  • Cough suppressant
  • Nasal decongestant
Section 55106-9 (55106-9)

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Drug Facts Night Maximum Strength Cold and Flu (DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU)

NIGHT MAXIMUM STRENGTH COLD AND FLU

Drug Facts Day Maximum Strength Cold and Flu (633t) (DRUG FACTS - DAY MAXIMUM STRENGTH COLD AND FLU (633T))

DAY MAXIMUM STRENGTH COLD AND FLU


Advanced Ingredient Data


Raw Label Data

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