XL-3 DAY TIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

XL-3 Day Time by

Drug Labeling and Warnings

XL-3 Day 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

Phenylephrine HCl 5 mg

PURPOSE

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE

Uses temporarily relieves common cold and flu symptoms:

nasal congestion cough due to minor throat and bronchial irritation

sore throat headache minor aches and pains fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if

• adult takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adults has 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

ras.

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

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 or 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.

ASK DOCTOR

Ask a doctor before use if you have

liver disease
heart disease
thyroid disease
diabete
high blood pressure
trouble urinating due to enlarged prostate gland
cough accompanied by excessive phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

WHEN USING

When using this product

• do not use more than directed (see overdose warning)
• avoid alcoholic drinks

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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.

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 problems 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 you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• take only as directed- 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 4 hours
• children 6 to under 12 years: 15 mL (1 TBSPO) every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

OTHER SAFETY INFORMATION

Other information

• each 15 mL contains: sodium 5 mg
• store between 58º - 86ºF (15º-30ºC).

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, FD&C Yellow No 6, 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 DAY TIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-441
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-441-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024
2	NDC: 84379-441-12	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)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-441)