DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hcl liquid

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

INDICATIONS & USAGE

Uses temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever

WARNINGS

Warnings

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

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 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

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 DOCTOR

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a sodium-restricted diet

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.

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over: 30 mL every 4 hrs
• children 6 to under 12 yrs: 15 mL every 4 hrs
• children 4 to under 6 yrs: ask a doctor
• children under 4 yrs: do not use

OTHER SAFETY INFORMATION

Other information

• each 15mL contains: sodium 56 mg
• store at no greater than 25°C and do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

772L - Albertsons 8 floz

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-947
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	orange (Clear orange)	Score
Shape		Size
Flavor	APRICOT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-947-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/11/2026

Labeler - BETTER LIVING BRANDS, LLC (009137209)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		677604129	manufacture(21130-947)