MULTI-SYMPTOM DAYTIME- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

MULTI-SYMPTOM DAYTIME by

Drug Labeling and Warnings

MULTI-SYMPTOM DAYTIME by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC, MEDGEL PRIVATE LIMITED, Elysium Pharmaceuticals Ltd, Ocean Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each softgel)                 Purposes
Acetaminophen 325 mg...............................Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg................Cough suppressant
Phenylephrine hydrochloride 5 mg.........................Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver
damage may occur if you take
■ more than 10 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

Sore throat warning:

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

When using this product

• do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• pain, nasal congestion or cough gets worse or last 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.

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

Keep out of reach of children.

Overdose warning

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

Directions

■ do not take more than the recommended dose
■ adults and children 12 years and over: take 2 softgels with water
every 4 hours. Do not exceed 10 softgels in 24 hours or as directed
by a doctor.
■ children under 12 years: do not use

Other information

•  store at room temperature. Avoid excessive heat above 40°c (104°F).

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, lecithin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Multi-symptom

Non-drowsy Daytime
Cold & Flu

Acetaminophen - Pain Reliever / Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant

Relief of:
Headache Body Ache Sore Throat
Nasal Congestion Sinus Pressure Cough

10 Softgels

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM DAYTIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-5000
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (Orange to Red)	Score	no score
Shape	CAPSULE (OBLONG)	Size	21mm
Flavor		Imprint Code	512;A09;AP01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-5000-1	1 in 1 CARTON	12/07/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/07/2022

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)