Drx Choice Capsule, Liquid Filled
FDA Label NDC 68163-062

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc. for the product Drx Choice (NDC 68163-062). 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 other, active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients (in Each Softgel)

→ 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

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Other

Drug Facts

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

TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Distributed by:
Raritan Pharmaceuticals
8 Joanna Court

East Brunswick, NJ 08816

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

▪cough due to minor throat & bronchial irritation
▪sore throat
▪headache
▪minor aches & pains
▪fever
▪runny nose & sneezing

Warnings

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

▪more than 8 softgels 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.

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.

Ask A Doctor Before Use If You Have

▪liver disease
▪glaucoma
▪cough that occurs with too much phlegm (mucus)
▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
▪trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

▪do not use more than directed
▪excitability may occur, especially in children
▪marked drowsiness may occur
▪avoid alcoholic drinks
▪be careful when driving a motor vehicle or operating machinery
▪alcohol, sedatives, & tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

▪pain 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

▪take only as directed
▪do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

store at room temperature

Inactive Ingredients

FD&C Blue No. 1, D&C Yellow No. 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide