Chloraseptic Nighttime Sore Throat Hot Relief Powder, For Solution
FDA Label NDC 67172-150

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Nighttime Sore Throat Hot Relief (NDC 67172-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each packet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Packet)

Acetaminophen 650 mg

Diphenhydramine HCL 25 mg

Purpose

Pain reliever

Antihistamine

Uses

Temporarily relieves symptoms of the common cold:

• minor aches and pains

• minor sore throat pain

• headache

• runny nose

• sneezing

• itchy throat or nose

• itchy, watery eyes due to hay fever

Warnings

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

• more than 5 doses in 24 hours, which is the maximum daily amount

• 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

Do Not Use

• in a child under 12 years of age

• if you are allergic to acetaminophen

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• with any other product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have

• liver disease

• glaucoma

• trouble urinating due to an enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

When Using This Product

• avoid alcoholic drinks

• marked drowsiness may occur

• alcohol, sedatives and tranquilizers may increase drowsiness

• be careful when driving a motor vehicle or operating machinery

• excitability may occur, especially in children

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

• do not use more than directed

• take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.

AgeDose
adults and children 12 years of age and overone packet
children under 12 years of agedo not use

• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

Other Information

• Each packet contains: potassium 5 mg and sodium 7 mg

• Store between 68°- 77° F (20°- 25° C)

• The inside packet is child-resistant

Inactive Ingredients

acacia, acesulfame potassium, acetic acid, anhydrous citric acid, caramel color, corn starch, honey, maltodextrin, natural flavor, silicon dioxide, sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate.

Questions?

1-800-552-7932

TAMPER EVIDENT: DO NOT USE IF PACKET IS DAMAGED OR OPEN

Principal Display Panel

Chloraseptic®

Nighttime

Sore Throat 

Soothing Hot Relief

Acetaminophen / Pain Reliever

Diphenhydramine HCL / Antihistamine

Honey Lemon Tea Flavor

Caffeine-Free

6 Packets

Chloraseptic® Nighttime Sore Throat Soothing Hot Reliefacetaminophen / Pain Relieverdiphenhydramine HCl / Antihistaminehoney Lemon Tea Flavorcaffeine-free6 Packets (Chloraseptic Nighttime Sore Throat Hot Relief   67 01)

Chloraseptic® Nighttime Sore Throat Soothing Hot Reliefacetaminophen / Pain Relieverdiphenhydramine HCl / Antihistaminehoney Lemon Tea Flavorcaffeine-free6 Packets (Chloraseptic Nighttime Sore Throat Hot Relief 67 01)

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