Label: TOPCARE FLU AND SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
- NDC Code(s): 36800-096-91
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 23, 2019
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- Active ingredients (in each packet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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
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
- in a child under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- do not use more than directed (see overdose warning)
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
adults and children 12 years of age and over
children under 12 years of age
do not use
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- Other information
- Inactive ingredients
- Questions or comments?
Package/Label Principal Display Panel
COMPARE TO THERAFLU® DAYTIME SEVERE COLD & COUGH ACTIVE INGREDIENTS
Flu & Severe Cold & Cough
PAIN RELIEVER – FEVER REDUCER (ACETAMINOPHEN)
COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)
NASAL DECONGESTANT (PHENYLEPHRINE HCl)
OUR PHARMACISTS RECOMMEND
FOR SOOTHING RELIEF OF:
Nasal & Sinus Congestion
Sore Throat Pain
BERRY INFUSED WITH MENTHOL FLAVOR
INGREDIENTS AND APPEARANCE
TOPCARE FLU AND SEVERE COLD AND COUGH DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-096 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color WHITE (mixture of white to light dark red particles) , RED Score Shape Size Flavor BERRY, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-096-91 6 in 1 CARTON; Type 0: Not a Combination Product 01/17/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/17/2012 Labeler - Topco Associates LLC (006935977)