Label: ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 73006-120-95 - Packager: O4 Global Trading Usa, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated November 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Purpose
- Uses:
-
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.
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 have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma.
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 drinks
• 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 serious underlying medical illness
• pain gets worse or lasts more than 10 days
• fever gets worse or last more than 3 days
• redness or swelling is present
• new symptoms occur.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
-
Directions:
• take with a full glass of water
• Do not take more than directed. SEE OVERDOSE WARNING.
• do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over • take 2 caplets at bedtime
• do not take more than 2 caplets of this product in 24 hours
children under 12 years of age • do not use - Other Information:
- Inactive Ingredients:
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
ADULT
PAIN RELIEVER NIGHTTIME SLEEP AID
TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing
Distributed By: O4 GLOBAL TRADING USA, LLC.
12222 Merit Drive, Suite 1900
Dallas, TX 75251-3209
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816.
- Packaging
-
INGREDIENTS AND APPEARANCE
ONLY FOR BODY PAIN
acetaminophen, diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (LIGHT BLUE) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code AD01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-120-95 1 in 1 CARTON 11/15/2020 1 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/15/2020 Labeler - O4 Global Trading Usa, Llc (081226861)
