TOPCARE DAY TIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

TopCare Day Time SEVERE Cold and Flu by

Drug Labeling and Warnings

TopCare Day Time SEVERE Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg 

Purposes

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

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

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 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only as directed
• do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over:

  2 softgels with water every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

store at 20-25°C (68-77°F) protect from light, heat and moisture

Inactive ingredients

edible printing ink, FD&C blue no.1, FD&C red no.40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

Call 1-888-423-0139

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COMPARE TO VICKS® DAYQUIL™ SEVERE COLD & FLU ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

Antihistamine Free

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and DayQuil™.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

QUALITY GUARANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO STVA0323 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

PRODUCT OF UNITED ARAB EMIRATES

REV.01-042023 CT761628114

Packaging

INGREDIENTS AND APPEARANCE

TOPCARE DAY TIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-811
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 BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	811
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-811-24	2 in 1 CARTON	11/03/2023
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 Drug	M012	11/03/2023

Labeler - Topco Associates LLC (006935977)