FDA Label for Acetaminophen Liquid / Acetaminophen Diphenhydramine Hcl Liquid

Daytime Pain Reliever

Drug Facts

Otc - Active Ingredient

Active ingredient (in each 30 mL)

Acetaminophen 1000 mg

Active ingredient (in each 30 mL)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Otc - Purpose

Purpose

Pain reliever

Purpose

Pain reliever

Nighttime sleep-aid

Indications & Usage

Uses for the temporary relief of minor aches and pains associated with:

• sore throat
• headache
• muscular aches
• backache

Uses

• for the temporary relief of minor aches and pains associated with accompanying sleeplessness.

Warnings

Warnings

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

• more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.

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.

Warnings

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

• more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.

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.

Otc - 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.

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.
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease
• a sodium-restricted diet

Ask a doctor before use if you have

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

Otc - Stop Use

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

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

Otc - 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 (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.

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.

Dosage & Administration

Directions

• take only as directed
• do not exceed 3 doses (30 mL each) per day (24 hours)
• only use the dose cup provided

adults & children 12 yrs & over	30 mL every 6 hours
children under 12 yrs	ask a doctor

Directions

• take only one dose (30 mL) per day (24 hours)
• only use the dose cup provided
• only use as directed

adults & children 12 yrs & over	30 mL at bedtime
children under 12 yrs	do not use

Other Safety Information

Other information

• each 30 mL contains: sodium 39 mg
• do not exceed 25°C and do not refrigerate.

Other information

• each 30 mL contains: sodium 39 mg
• do not exceed 25°C and do not refrigerate.

Inactive Ingredient

Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, polysorbate 20, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Otc - Questions

Questions or comments? Call 1-877-290-4008

Questions or comments? Call 1-877-290-4008

Nighttime Pain Reliever And Sleep Aid

Drug Facts

Otc - When Using

When using this product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate machinery