Active Ingredients
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Counteract Tablet
FDA Label NDC 54473-304
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Counteract (NDC 54473-304). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, do not use, warnings, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- in children under 12 years of age
- if you are allergic to acetaminophen or any of the ingredients in this product
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, which is the maimum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 (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.
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a searious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse of lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Purpose
Pain reliever
Nighttime sleep-aid
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use.
Other Information
- store at controlled room temperature 15-30 oC (59-86 oF)
- see end flap for expiration date and lot number
Questions Or Comments?
If you have any questions or comments, or to report an adverse even, please contact 1-800-282-3000.
Inactive Ingredients
calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,
magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.
Do Not Take This Product Unless Directed By A Doctor If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
Uses
temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness
Package Label.Principal Display Panel
Bottle (Counteractpm Bottle)
Box (Counteractpm Box)
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