DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS- acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

Daytime Severe Cold and Flu Relief Softgels by

Drug Labeling and Warnings

Daytime Severe Cold and Flu Relief Softgels by is a Otc medication manufactured, distributed, or labeled by TopCo Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Guaifenesin 200 mg

Phenlyephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• ■ temporarily relieves common cold/flu
  symptoms: ■ nasal congestion ■ sinus
  congestion & pressure ■ cough due to minor throat
  & bronchial irritation ■ minor aches & pains
  ■ headache ■ fever ■ sore throat
  ■ reduces swelling of nasal passages ■ temporarily
  restores freer breathing through the nose
  ■ promotes nasal and/or sinus drainage
  ■ helps loosen phlegm (mucus) and thin bronchial
  secretions to rid the bronchial passageways of
  bothersome mucus and make coughs more
  productive.

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

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 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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.

Directions

■ take only as directed
■ do not exceed 8 softgels per 24 hours 

• adults & children 12 years & over: 2 softgels with water ; every 4 hours
• children 4 to under 12 years: ask a doctor
• children under 4 years: do not use

 ■ when using other Nighttime or Daytime products,
carefully read each label to ensure correct dosing

Other information

• ■ store at room temperature

Inactive ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol
sorbitan solution, titanium dioxide

QUESTIONS

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Vicks® DayQuil® Cold & Flu*

MAXIMUM STRENGTH

Daytime Softgels

Severe Cold/Flu Relief

ACETAMINOPHEN - Pain reliever; fever reducer

DEXTROMETHORPHAN HBr - Cough Suppressant

GUAIFENESIN- Expectorant

PHENYLEPHRINE HCl - Nasal Decongestant

Relieves:
Headache, Fever, Sore throat, Minor aches
& pains, Cough, Chest congestion, Nasal/Sinus
congestion & Sinus pressure
Non-drowsy
Alcohol free
Antihistamine free

24 SOFTGELS

THIS PRODUCT IS
PACKAGED IN A
CHILD-RESISTANT AND
TAMPER-EVIDENT
PACKAGE. USE ONLY IF
BLISTERS ARE INTACT.

*This product is not
manufactured or distributed
by Procter & Gamble, owner
of the registered trademarks
Vicks® DayQuil® Severe Cold
& Flu.

INGREDIENTS AND APPEARANCE

DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS 
acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-655
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (Light Orange)	Score	no score
Shape	CAPSULE (oblong shaped)	Size	20mm
Flavor		Imprint Code	341
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-655-24	2 in 1 CARTON	10/31/2019
1		12 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 final	part341	10/31/2019

Labeler - TopCo Associates LLC (006935977)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(36800-655)