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Daytime Nighttime Cold and Flu (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet) Dailymed



IMPRINT: AAA 1165     SHAPE: oval
    COLOR: red

All Imprints

acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet - aaa 1165 oval red

acetaminophen 325 mg diphenhydramine hydrochloride 25 mg phenylephrine hydrochloride 5 mg - aaa 1116 oval blue

{10 (acetaminophen 325 mg / diphenhydramine hydrochloride 25 mg / phenylephrine hydrochloride 5 mg oral tablet) / 10 (acetaminophen 325 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet) } pack - aaa 1116 oval blue

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each Day Time caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

OTC - PURPOSE SECTION

Active ingredients (in each Night Time caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough (DAY TIME SEVERE COLD ONLY)
    • minor aches and pains
    • headache
    • sore throat
    • runny nose and sneezing (NIGHT TIME COLD & FLU ONLY)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME SEVERE COLD ONLY)
  • temporarily reduces fever

Warnings


Liver warning


This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert


acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • 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 (NIGHT TIME COLD & FLU ONLY)
  • 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.
  • for children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT TIME COLD & FLU ONLY)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME COLD & FLU ONLY)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME SEVERE COLD ONLY)
  • cough that occurs with too much phlegm (mucus) (DAY TIME SEVERE COLD ONLY)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (NIGHT TIME COLD & FLU ONLY)

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT TIME COLD & FLU ONLY)
  • marked drowsiness may occur (NIGHT TIME COLD & FLU ONLY)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME COLD & FLU ONLY)
  • avoid alcoholic drinks (NIGHT TIME COLD & FLU ONLY)
  • be careful when driving a motor vehicle or operating machinery (NIGHT TIME COLD & FLU ONLY)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Overdose warning


Taking more than the recommended dose (overdose) may cause liver damage. 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 Day Time and Night Time caplets at the same time
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store between 20-25°C (68-77°F) in a dry place
  • keep outer package for complete product information

Inactive Ingredients


DAY TIME SEVERE COLD


colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

NIGHT TIME COLD & FLU


colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions Or Comments?


1-844-705-4384

Principal Display Panel


CVS Health®

NDC 69842-477-03

MAXIMUM STRENGTH®

Daytime Cold & Flu

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal decongestant

MULTI-SYMPTOM

Headache + Body Pain

Fever + Sore Throat

Cough + Chest Congestion

Nasal Congestion

FOR AGES 12+

Actual Size

20 DAYTIME CAPLETS

MAXIMUM STRENGTH*

Nighttime Cold & Flu

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine

Phenylephrine HCl

Nasal decongestant

MULTI-SYMPTOM

Headache + Body Pain

Fever + Sore Throat

Nasal Congestion

Sneezing & Runny Nose

FOR AGES 12+

Actual Size

10 NIGHTTIME CAPLETS

TOTAL 30 CAPLETS



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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