XL-3 NIGHT TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

XL-3 Night Time by

Drug Labeling and Warnings

XL-3 Night Time by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 12.5 mg

PURPOSE

Pain reliever/fever reducer

Cough Suppressant

Antihistamine

INDICATIONS & USAGE

Uses

temporarily relieves cold/flu symptoms:

• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing
• cough due to minor throat and bronchial irritation

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Sever 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 sever skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is sever, lasts 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 products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• to make a child sleepy

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have

• a sodium restricted diet
• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs wtih 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
• if you are taking the blood thinning drug warfarin.

WHEN USING

When using this product

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

STOP USE

Stop use and ask a doctor if

• redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• rever gets worse or lasts more than 3 days
• new symptoms occur
• cough lasts more than 7 days, comes back, or occurs wih fever, rash or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental 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 children even if ou do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

• take only as recommended- see Overdose warning
• use only dosing cup provided
• keep dosing cup provided with the product
• do not exceed 4 doses per 24 hours
• if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours
• TBSP=tablespoon
• mL=mililiter

• adults & children 12 years and over: 30 mL (2 TBSP) every 6 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

OTHER SAFETY INFORMATION

Other information

• each 30 mL contains: sodium 10 mg
• store between 58 - 86 degrees F (15-30 degrees C)

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

QUESTIONS

Questions or Comments? 1-888-446-4753

Monday - Friday from 8 AM - 5 PM Eastern Standard Time

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XL-3 NIGHT TIME 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-444
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	350 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-444-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84379-444-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2024

Labeler - Rnv LLC (118917568)