633t Family Dollar Night Maximum Strength Cold And Flu 55319-934-08

633t Family Dollar Night Maximum Strength Cold And Flu 55319-934-08
SPL v4
SPL
SPL Set ID aa8f0465-1595-0b0f-e053-2a95a90a0081
Route
ORAL
Published
Effective Date 2020-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Active ingredients (in each SOFTGEL) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine Succinate 6.25 mg Phenylephrine hydrochloride 5 mg


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

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Dosage and Administration

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 softgels 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

Active ingredients (in each SOFTGEL) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine Succinate 6.25 mg Phenylephrine hydrochloride 5 mg

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
  • Pain Reliever-Fever Reducer
  • Cough Suppressant
  • Antihistamine
  • Nasal Decongestant
Section 55106-9

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine hydrochloride 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Dosage and Administration (34068-7)

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 softgels 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)
  • Pain Reliever-Fever Reducer
  • Cough Suppressant
  • Antihistamine
  • Nasal Decongestant
Section 55106-9 (55106-9)

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine hydrochloride 5 mg


Advanced Ingredient Data


Raw Label Data

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