Topco Associates LLC. Cold & Flu Night Time Drug Facts
topcare cold and flu night time by
Drug Labeling and Warnings
topcare cold and flu night time by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
TOPCARE COLD AND FLU NIGHT TIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Topco Associates LLC
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.
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Topco Associates LLC. Cold & Flu Night Time Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- temporarily reduces fever
Warnings
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
- 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.
- with any other product containing diphenhydramine, even one used on skin
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 10 caplets in any 24-hour period
- adults and children 12 years of age and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Inactive ingredients
crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Package/Label Principal Display Panel
COMPARE TO MUCINEX® FAST-MAX® NIGHT TIME COLD & FLU CAPLETS ACTIVE INGREDIENTS
NIGHTTIME
MAXIMUM STRENGTH
Cold & Flu Night Time
PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN
ANTIHISTAMINE – DIPHENHYDRAMINE HCl
NASAL DECONGESTANT – PHENYLEPHRINE HCl
OUR PHARMACISTS RECOMMEND
Relieves Aches, Fever & Sore Throat
Relieves Nasal Congestion
Relieves Runny Nose & Sneezing
20 CAPLETS
actual size
| TOPCARE COLD AND FLU NIGHT TIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated |
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| Labeler - Topco Associates LLC (006935977) |
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