Acetaminophen and Diphenhydramine HCl Captabs
Drug Labeling and Warnings
Drug Details [pdf]
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL- acetaminophen and diphenhydramine hcl tablet
Rugby Laboratories Inc.
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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Acetaminophen and Diphenhydramine HCl Captabs
Uses
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 captabs in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product.
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 drug containing diphenhydramine, even one used on skin
- in children under 12 years of age
- Ask a doctor before use if you have
- liver 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
- marked drowsiness will occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- do not drive motor vehicle or operate machinery
- Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
- sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.
- If pregnant or breast feeding, ask a health professional before use.
- Keep out of children.
- In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
adults and children 12 years or over:
- take 2 captabs at bedtine if needed
- do not take more than directed
childrens under 12 years do not use
Inactive Ingredients
Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
50 Captabs Bottle Carton
NDC: 0536-3479-06
Rugby
ACETAMINOPHEN 500 mg / Diphenhydramine HCl 25 mg
Pain Reliever / Sleep Aid
50 Captabs
| ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
acetaminophen and diphenhydramine hcl tablet |
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| Labeler - Rugby Laboratories Inc. (079246066) |